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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK116733 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| The Community Health and Social Services Center, Inc. | OTHER |
| University of Michigan | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The objective of this study is to compare the effectiveness of a novel program-Family Support for Health Action (FAM-ACT) - to individual patient-focused diabetes self-management education and support (I-DSMES).
FAM-ACT uses three innovative approaches to enhance the impact of family support on diabetes management for adults with diabetes (AWDs):
FAM-ACT will be developed and implemented in culturally-concordant ways, in partnership with the community participating in the program.
Adults with type 2 diabetes and either poor glycemic or blood pressure control will be randomized together with a Support Person (a chosen adult family member or friend) to receive either FAM-ACT or more traditional CHW-led patient-focused I-DSMES over 6 months.
See our published protocol (Deverts et al 2022; full citation in references section) for additional details on the protocol including any changes made after the study started.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FAM-ACT | Experimental | Patient and Support Person (dyad) will be included together as much as possible. The dyad will:
|
|
| I-DSMES | Active Comparator | This arm will focus on the patient only. The Support Person assigned to this arm will not be invited to the introduction sessions, care management contacts, or diabetes self-management education sessions. Patients assigned to this arm will:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAM ACT | Behavioral | Patient and Support Person (dyad) will receive a Diabetes Complications Risk Assessment profile and introduction session, Support Person-focused information/skills training through 4-6 extended DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Patient Glycemic Control at 6 Months | Hemoglobin A1c (HbA1c, percent) was measured via finger stick performed by a study research assistant, by a clinician as a part of the patients' regular care, or by patients via home test kit. For analysis, HbA1c first was examined graphically to understand how it changed over time. Main analyses then were conducted using linear mixed-effects models, with 12-month HbA1c values included in the models to increase the power to estimate changes over the initial 6 months. Adjusted outcome and effect estimates at 6 months were derived from linear mixed models using linear contrasts. The model was fitted using all available time points (baseline, 6 months, and 12 months) from all 222 enrollees to make efficient use of the data. Including all time points allows the model to account for individual trajectories over time, thus increasing power to detect treatment effects and reducing bias that could arise from analyzing the 6-month time point in isolation. | Baseline vs. 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Patient Glycemic Control at 12 Months | Hemoglobin A1c (HbA1c, percent) was measured through finger stick performed by a study research assistant, by a clinician as a part of the patients' regular care, or by the patients themselves via a home test kit. | Baseline vs. 12 months |
| Change From Baseline in Patient Systolic Blood Pressure at 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diabetes Self-care Behaviors in Patient: Healthy Eating | The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence. |
Patient Inclusion Criteria:
Patient Exclusion Criteria:
Support Person Inclusion Criteria:
Support Person Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann-Marie Rosland, MD,MS | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Health and Social Services Center (CHASS) | Detroit | Michigan | 48209 | United States | ||
| University of Pittsburgh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36192769 | Background | Deverts DJ, Heisler M, Kieffer EC, Piatt GA, Valbuena F, Yabes JG, Guajardo C, Ilarraza-Montalvo D, Palmisano G, Koerbel G, Rosland AM. Comparing the effectiveness of Family Support for Health Action (FAM-ACT) with traditional community health worker-led interventions to improve adult diabetes management and outcomes: study protocol for a randomized controlled trial. Trials. 2022 Oct 3;23(1):841. doi: 10.1186/s13063-022-06764-1. | |
| 35301642 | Background |
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The study investigators will make de-identified data sets available for sharing after the trial is finished and primary analyses have been completed and published. Researchers requesting data must present an IRB-approved methodological protocol and explain the relevance of their interest in the study completed data to public health goals. Authors completing secondary analyses of the shared study data must agree to the Center for Clinical Trials and Data Coordination (CCDC) policy on data sharing and publishing. All secondary analysis authors will be expected to credit the primary investigators and mention the data source in all publications. Secondary authors will acknowledge that the data use was in accordance with CCDC protocol and the signed Data Use Agreement (DUA). The University of Pittsburgh Principal Investigator and study coordinator will not release any data until all request criteria are met and a signed Data Use Agreement is filed.
The data will become available beginning 6 months and ending 36 months after the primary trial results are published.
All access will be thru the Center for Clinical Trials & Data Coordination (CCDC) at the University of Pittsburgh. Access will be monitored and controlled by our data center. No access will be granted until the initial requesting investigator vetting process is completed and a signed DUA is on file. All data safety plans and monitoring are listed on the CCDC website. Researchers interested in the data must sign a data use agreement (DUA) with the University of Pittsburgh, which must also be reviewed and agreed to by study partner CHASS Center Inc. No other data sharing options will be considered. The data that may be shared includes: de-identified participant data, tables, figures, appendices, analysis plan, and protocol.
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No enrolled participants were excluded before being assigned to a study arm.
Patients were recruited from a Federally Qualified Health Center (FQHC) in the mid-western US that serves a low SES, primarily Spanish-speaking population. Enrollment took place from Sep. 2019 to Dec. 2022, with a several month pause between Mar. 2020 and Feb. 2021 when restrictions were placed on in-person research. Potential participants were identified via FQHC EHR or clinician referral, and recruited by letter and phone. Support Persons were identified by patients and recruited by phone.
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| ID | Title | Description |
|---|---|---|
| FG000 | FAM-ACT - Patients | FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals. |
| FG001 | I-DSMES - Patients | The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, but they will not receive any SP-focused information. |
| FG002 | FAM-ACT - Support Persons | FAM-ACT is a diabetes self-management education and support (DSMES) intervention for adults with type 2 diabetes ('patients') and their support persons ('SP'). The intervention consists of 3 components: an introductory session with a community health worker (CHW), 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. Patients and SPs are encouraged to take part in all components together. The introductory session is designed to provide an overview of diabetes complications, ways the SP and patient can work together positively, and ways to set 'SMART' health goals. During this session results of a diabetes complication risk profile are discussed with the patient and SP and the dyad learns how to set goals together. The 6 DSMES sessions last 45 minutes to 1 hour and can be conducted in person or virtually. Each topical session is enhanced with a discussion of progress toward SPs increasing their involvement in the patient's diabetes management, and skills SPs can use to address the diabetes management topics covered in the session. SP-enhanced sessions also include discussions about positive communication techniques and patient-SP weekly talks about diabetes. Patients and SPs also receive bimonthly care management calls from a CHW by phone or video chat. Calls last about 20 minutes during which the CHW discusses with the dyad the patients' progress toward their goals and ways the SP can help the patient achieve those goals. |
| FG003 | I-DSMES - Support Persons | The individual patient-focused DSMES intervention (I-DSMES) is comprised of the same 3 components described for FAM-ACT: an introductory session with a CHW, 6 CHW-led DSMES sessions based on an ADA-approved DSMES curriculum, and twice-monthly care management calls. I-DSMES differs from FAM-ACT in that the DSMES sessions are not enhanced with support-focused information and SPs are not invited to participate in the intervention with the patient. SPs in the I-DSMES arm may attend the DSMES sessions if they choose to do so, bu |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| Intervention |
| |||||||||||||
| 6-month Follow-up |
| |||||||||||||
| 12-month Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FAM-ACT-Patients | Patient and Support Person (dyad) will be included together as much as possible. The dyad will:
FAM ACT: Patient and Support Person (dyad) will receive a Diabetes Complications Risk Assessment profile and introduction session, Support Person-focused information/skills training through 4-6 extended DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Patient Glycemic Control at 6 Months | Hemoglobin A1c (HbA1c, percent) was measured via finger stick performed by a study research assistant, by a clinician as a part of the patients' regular care, or by patients via home test kit. For analysis, HbA1c first was examined graphically to understand how it changed over time. Main analyses then were conducted using linear mixed-effects models, with 12-month HbA1c values included in the models to increase the power to estimate changes over the initial 6 months. Adjusted outcome and effect estimates at 6 months were derived from linear mixed models using linear contrasts. The model was fitted using all available time points (baseline, 6 months, and 12 months) from all 222 enrollees to make efficient use of the data. Including all time points allows the model to account for individual trajectories over time, thus increasing power to detect treatment effects and reducing bias that could arise from analyzing the 6-month time point in isolation. | Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete HbA1c data at both baseline and 6-months post-baseline. | Posted | Mean | 95% Confidence Interval | percentage | Baseline vs. 6 months |
Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment.
Study staff were trained to report all AEs and potential problems immediately. Also, the informed consent document contained contact information for the PI and University of Pittsburgh IRB to facilitate self-report of AEs. SAEs were to be categorized by the study monitor according to the CTCAE. The PI or Site-PI were responsible for adjudicating all SAEs with the aid of discharge summaries.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FAM-ACT-Patients | Patient and Support Person (dyad) will be included together as much as possible. The dyad will:
FAM ACT: Patient and Support Person (dyad) will receive a Diabetes Complications Risk Assessment profile and introduction session, Support Person-focused information/skills training through 4-6 extended DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (Unspecified) | Non-systematic Assessment | Abdominal pain and/or vomiting requiring hospital admission. Unrelated to study participation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | CTCAE (Unspecified) | Non-systematic Assessment | Tested positive for COVID-19. Unrelated to study participation. |
Many patients were due for the 6-month A1c measure (main outcome) during the height of the COVID-19 pandemic when restrictions on face-to-face research activities prevented us from collecting the data and they missed this outcome window. Two compensatory strategies were enacted: (a) review patients' EHR to identify additional A1c data during the collection window and (b) send patients home A1c test kits. This did yield some additional data, but we still missed 6-month A1c data for many patients.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ann-Marie Rosland, MD, MS | University of Pittsburgh School of Medicine | 412-648-5660 | roslandam@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 22, 2022 | Jan 17, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 22, 2022 | Jan 17, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 7, 2022 | Aug 3, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006973 | Hypertension |
| D006943 | Hyperglycemia |
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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This is a randomized comparative effectiveness trial comparing two interventions.
The participants and staff delivering the interventions will not be blinded, but the data analyst will be.
This trial aims to compare the effect of the FAM-ACT intervention on patients' diabetes-related health behaviors and outcomes compared to patient-focused DSME and support (I-DSMES).
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Outcomes Assessor will be unaware of the arm assignment of the participant when assessing main outcomes.
|
|
| I-DSMES | Behavioral | Patient only will receive a Diabetes Complications Risk Assessment profile and introduction session, 4-6 group DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments. |
|
|
SBP was measured using an electronic, upper arm blood pressure monitor. |
| Baseline vs. 6 months |
| Change From Baseline in Patient Systolic Blood Pressure at 12 Months | SBP was measured using an electronic, upper arm blood pressure monitor. | Baseline vs. 12 months |
| Change From Baseline in Patient Diabetes Distress at 6 Months | Patient diabetes distress was assessed using the Problem Areas in Diabetes (PAID-5) Scale. The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items were summed to create a total score with a range of 0 to 20. A total score of >=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress. | Baseline vs. 6 months |
| Change From Baseline in Patient Diabetes Distress at 12 Months | Patient diabetes distress was assessed using the Problem Areas in Diabetes (PAID-5) Scale. The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items were summed to create a total score with a range of 0 to 20. A total score of >=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress. | Baseline vs. 12 months |
| Change From Baseline Patient Diabetes Self-care Behaviors at 6 Months: Healthy Eating | The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence. | Baseline vs. 6 months |
| Change in Diabetes Self-care Behaviors in Patient: Physical Activity | The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence. | Baseline vs. 6 months |
| Change in Diabetes Self-care Behaviors in Patient: Medication Adherence | The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence. Three types of medication adherence were assessed: number of days diabetes medications (non-insulin) were taken; number of days blood pressure medications were taken; number of days cholesterol medications were taken. Note that the Ns with data for these three measures are smaller than the Ns for diet and physical activity data. Differences are due to some patients not having been prescribed non-insulin diabetes, blood pressure and/or cholesterol medications. | Baseline vs. 6 months |
| Change in Self-efficacy of Patient | Patient self-efficacy for managing diabetes was assessed with the Self-Efficacy for Managing Chronic Diseases Scale. The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can perform tasks related to their diabetes management (0, not at all confident to 10, very confident). Item responses are averaged, with mean scores ranging from 0 to 10. Higher numbers indicate greater self-efficacy. | Baseline vs. 6 months |
| Change in Patient Activation in Patient | Patient activation was assessed with the Patient Activation Measure (PAM)-10. Using a 4-point scale (1=strongly disagree to 4=strongly agree), respondents indicate the extent to which statements related to being ready, willing and able to manage their health and health care accurately describe them. Responses are summed to create a total score with higher numbers indicating greater activation. Item scale locations were transformed from the original logit metric to a user-friendly 0-100 metric where 0=the lowest possible activation and 100=the highest possible activation as measured by this set of items. While the metric allows for a potential range of 0-100, the items included in the measure only covered the range from 40 (minimum) to 60 (maximum), not tapping what would be theoretically the lowest or highest ranges of the construct. | Baseline vs. 6 months |
| Patient Perceived Overall Satisfaction With SP Support for Diabetes | Patient satisfaction with support person (SP) support for diabetes was assessed with 2* items assessing patient's satisfaction with the support they receive from their SP and whether they feel like they would be worse off without their SP's help with their diabetes care. Responses were rated on a 7-point scale ranging from 1, "strongly disagree" to 7 "strongly agree". Responses are summed to create a total score with a range of 2 to 14. Higher numbers indicate greater satisfaction. | Baseline vs. 6 months |
| Patient Perception of SP Support: Supportive and Non-supportive Behaviors | Patient perception of support persons' (SP) supportive behaviors was assessed using the 8-item Important Other Climate Questionnaire (IOCQ) and non-supportive behaviors using 3 similarly-structured items addressing SP irritation, criticism and argumentativeness. All items are rated on a 7-point scale ranging from 0 ("strongly disagree") to 6 ("strongly agree"), with non-supportive behavior items being reversed scored. Item responses were averaged to create a mean score with a possible range of 0 (low support) to 6 (high support). | Baseline vs. 6 months |
| Impact of COVID on Ability to Manage Diabetes | Impact of COVID on ability to manage Diabetes was assessed with a single closed-ended item: "In the last six months, how have the COVID pandemic or social distancing rules affected your ability to manage your diabetes?" The item is rated on a 5-point scale ranging from "much harder" to "much easier". Due to small numbers, the variable was collapsed to 3 categories for analysis: harder/much harder, no change, easier/much easier. | Cross-sectional at 6 months |
| Change in Diabetes Distress in Support Person | Support person distress about the patient's diabetes was assessed using the Problem Areas in Diabetes (PAID-5) Scale (for family members). The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items were summed to create a total score with a range of 0 to 20. A total score of >=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress. | Baseline vs. 6 months |
| Change in Self-efficacy of Support Person | Support person self-efficacy for helping the patient with managing diabetes was assessed with the Self-Efficacy for Managing Chronic Diseases Scale (adapted for support persons). The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can help patients perform tasks related to their diabetes management (0, not at all confident to 10, very confident). Item responses are averaged, with mean scores ranging from 0 to 10. Higher numbers indicate greater self-efficacy. | Baseline vs. 6 months |
| Baseline vs. 12 months |
| Change in Diabetes Self-care Behaviors in Patient: Physical Activity | The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence. | Baseline vs. 12 months |
| Change in Diabetes Self-care Behaviors in Patient: Medication Adherence | The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence. Three types of medication adherence were assessed: number of days diabetes medications (non-insulin) were taken; number of days blood pressure medications were taken; number of days cholesterol medications were taken. Note that the Ns with data for these three measures are smaller than the Ns for diet and physical activity data. Differences are due to patients not having been prescribed non-insulin diabetes, blood pressure and/or cholesterol medications. | Baseline vs. 12 months |
| Change in Self-efficacy of Patient | Patient self-efficacy for managing diabetes was assessed with the Self-Efficacy for Managing Chronic Diseases Scale. The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can perform tasks related to their diabetes management (0, not at all confident to 10, very confident). Item responses are averaged, with mean scores ranging from 0 to 10. Higher numbers indicate greater self-efficacy. | Baseline vs. 12 months |
| Change in Patient Activation in Patient | Patient activation was assessed with the Patient Activation Measure (PAM)-10. Using a 4-point scale (1=strongly disagree to 4=strongly agree), respondents indicate the extent to which statements related to being ready, willing and able to manage their health and health care accurately describe them. Responses are summed to create a total score with higher numbers indicating greater activation. Item scale locations were transformed from the original logit metric to a user-friendly 0-100 metric where 0=the lowest possible activation and 100=the highest possible activation as measured by this set of items. While the metric allows for a potential range of 0-100, the items included in the measure only covered the range from 40 (minimum) to 60 (maximum), not tapping what would be theoretically the lowest or highest ranges of the construct. | Baseline vs. 12 months |
| Patient Perceived Overall Satisfaction With Support Person Support for Diabetes | Patient satisfaction with support person (SP) support for diabetes was assessed with 2* items assessing patient's satisfaction with the support they receive from their SP and whether they feel like they would be worse off without their SP's help with their diabetes care. Responses were rated on a 7-point scale ranging from 1, "strongly disagree" to 7 "strongly agree". Responses are summed to create a total score with a range of 2 to 14. Higher numbers indicate greater satisfaction. | Baseline vs. 12 months |
| Patient Perception of Support Person Support: Supportive and Non-supportive Behaviors | Patient perception of support persons' (SP) supportive behaviors was assessed using the 8-item Important Other Climate Questionnaire (IOCQ) and non-supportive behaviors using 3 similarly-structured items addressing SP irritation, criticism and argumentativeness. All items are rated on a 7-point scale ranging from 0 ("strongly disagree") to 6 ("strongly agree"), with non-supportive behavior items being reversed scored. Item responses were averaged to create a mean score with a possible range of 0 (low support) to 6 (high support). | Baseline vs. 12 months |
| Change in Diabetes Distress in Support Person | Support person distress about the patient's diabetes was assessed using the Problem Areas in Diabetes (PAID-5) Scale (for family members). The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items were summed to create a total score with a range of 0 to 20. A total score of >=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress. | Baseline vs. 12 months |
| Change in Self-efficacy of Support Person | Support person self-efficacy for helping the patient with managing diabetes was assessed with the Self-Efficacy for Managing Chronic Diseases Scale (adapted for support persons). The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can help patients perform tasks related to their diabetes management (0, not at all confident to 10, very confident). Item responses are averaged, with mean scores ranging from 0 to 10. Higher numbers indicate greater self-efficacy. | Baseline vs. 12 months |
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| Zupa MF, Perez S, Palmisano G, Kieffer EC, Piatt GA, Valbuena FM, Deverts DJ, Yabes JG, Heisler M, Rosland AM. Changes in Self-management During the COVID-19 Pandemic Among Adults with Type 2 Diabetes at a Federally Qualified Health Center. J Immigr Minor Health. 2022 Oct;24(5):1375-1378. doi: 10.1007/s10903-022-01351-7. Epub 2022 Mar 17. |
| 41958056 | Derived | Deverts DJ, F Zupa M, Kieffer EC, Piatt GA, Heisler M, Valbuena F, Gonzalez S, Guajardo C, Yabes JG, Lalama C, Rosland AM. Transition to Virtual Diabetes Self-Management Education Delivery in the Setting of Health Care Disruption for Adults With Diabetes and Their Support Persons. Sci Diabetes Self Manag Care. 2026 Jun;52(3):229-242. doi: 10.1177/26350106261432172. Epub 2026 Apr 9. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED | The criterion for completing the 6-month assessment differed for patients and Support Persons. For patients, completion required having a 6-month hemoglobin A1c (A1c) value obtained either during a study visit or during a clinic visit scheduled near the time of the 6-month follow up. For Support Persons, completion of this study period was based on their completing the follow up survey assessment. |
|
| NOT COMPLETED |
|
|
| COMPLETED | The criterion for completing the 12-month assessment differed for patients and Support Persons. For patients, completion required having a 12-month hemoglobin A1c (A1c) value obtained either during a study visit or during a clinic visit scheduled near the time of the 12-month follow up. For Support Persons, completion of this study period was based on their completing the follow up survey assessment. |
|
| NOT COMPLETED |
|
|
| BG001 | I-DSMES-Patients | This arm will focus on the patient only. The Support Person assigned to this arm will not be invited to the introduction sessions, care management contacts, or diabetes self-management education sessions. Patients assigned to this arm will:
I-DSMES: Patient only will receive a Diabetes Complications Risk Assessment profile and introduction session, 4-6 group DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments. |
| BG002 | FAM-ACT-Support Persons | Patient and Support Person (dyad) will be included together as much as possible. The dyad will:
FAM ACT: Patient and Support Person (dyad) will receive a Diabetes Complications Risk Assessment profile and introduction session, Support Person-focused information/skills training through 4-6 extended DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments. |
| BG003 | I-DSMES-Support Persons | This arm will focus on the patient only. The Support Person assigned to this arm will not be invited to the introduction sessions, care management contacts, or diabetes self-management education sessions. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | A large proportion of participants reported "other" as their race because they identify as Latino/Hispanic for both their ethnicity and race | Count of Participants | Participants |
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| Hemoglobin A1c (A1c) | The main outcome, change in A1c from baseline to 6 months, was assessed for patient participants only. | The main outcome, change in A1c from baseline to 6 months, was assessed for patient participants only. SP participants were not included in the analysis. | Mean | Standard Deviation | % |
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| Secondary | Change From Baseline in Patient Glycemic Control at 12 Months | Hemoglobin A1c (HbA1c, percent) was measured through finger stick performed by a study research assistant, by a clinician as a part of the patients' regular care, or by the patients themselves via a home test kit. | Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete HbA1c data at both baseline and 12-months post-baseline. | Posted | Mean | 95% Confidence Interval | percentage | Baseline vs. 12 months |
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| Secondary | Change From Baseline in Patient Systolic Blood Pressure at 6 Months | SBP was measured using an electronic, upper arm blood pressure monitor. | Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete SBP data at both baseline and 6-months post-baseline. | Posted | Mean | 95% Confidence Interval | mmHg | Baseline vs. 6 months |
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| Secondary | Change From Baseline in Patient Systolic Blood Pressure at 12 Months | SBP was measured using an electronic, upper arm blood pressure monitor. | Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete SBP data at both baseline and 12-months post-baseline. | Posted | Mean | 95% Confidence Interval | mmHg | Baseline vs. 12 months |
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| Secondary | Change From Baseline in Patient Diabetes Distress at 6 Months | Patient diabetes distress was assessed using the Problem Areas in Diabetes (PAID-5) Scale. The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items were summed to create a total score with a range of 0 to 20. A total score of >=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress. | Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete PAID-5 data at both baseline and 6-months post-baseline. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline vs. 6 months |
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| Secondary | Change From Baseline in Patient Diabetes Distress at 12 Months | Patient diabetes distress was assessed using the Problem Areas in Diabetes (PAID-5) Scale. The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items were summed to create a total score with a range of 0 to 20. A total score of >=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress. | Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete PAID-5 data at both baseline and 12-months post-baseline. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline vs. 12 months |
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| Secondary | Change From Baseline Patient Diabetes Self-care Behaviors at 6 Months: Healthy Eating | The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence. | Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete SDSCA diet data at both baseline and 6-months post-baseline. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline vs. 6 months |
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| Secondary | Change in Diabetes Self-care Behaviors in Patient: Physical Activity | The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence. | Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete SDSCA physical activity data at both baseline and 6-months post-baseline. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline vs. 6 months |
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| Secondary | Change in Diabetes Self-care Behaviors in Patient: Medication Adherence | The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence. Three types of medication adherence were assessed: number of days diabetes medications (non-insulin) were taken; number of days blood pressure medications were taken; number of days cholesterol medications were taken. Note that the Ns with data for these three measures are smaller than the Ns for diet and physical activity data. Differences are due to some patients not having been prescribed non-insulin diabetes, blood pressure and/or cholesterol medications. | Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 patient participants enrolled in the study. Ns represent the number of adult patients with type 2 diabetes who had complete adherence data for diabetes, blood pressure, and cholesterol medications, respectively, at both baseline and 6-months post-baseline. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline vs. 6 months |
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| Secondary | Change in Self-efficacy of Patient | Patient self-efficacy for managing diabetes was assessed with the Self-Efficacy for Managing Chronic Diseases Scale. The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can perform tasks related to their diabetes management (0, not at all confident to 10, very confident). Item responses are averaged, with mean scores ranging from 0 to 10. Higher numbers indicate greater self-efficacy. | Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete self-efficacy data at both baseline and 6-months post-baseline. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline vs. 6 months |
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| Secondary | Change in Patient Activation in Patient | Patient activation was assessed with the Patient Activation Measure (PAM)-10. Using a 4-point scale (1=strongly disagree to 4=strongly agree), respondents indicate the extent to which statements related to being ready, willing and able to manage their health and health care accurately describe them. Responses are summed to create a total score with higher numbers indicating greater activation. Item scale locations were transformed from the original logit metric to a user-friendly 0-100 metric where 0=the lowest possible activation and 100=the highest possible activation as measured by this set of items. While the metric allows for a potential range of 0-100, the items included in the measure only covered the range from 40 (minimum) to 60 (maximum), not tapping what would be theoretically the lowest or highest ranges of the construct. | Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete patient activation data at both baseline and 6-months post-baseline. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline vs. 6 months |
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| Secondary | Patient Perceived Overall Satisfaction With SP Support for Diabetes | Patient satisfaction with support person (SP) support for diabetes was assessed with 2* items assessing patient's satisfaction with the support they receive from their SP and whether they feel like they would be worse off without their SP's help with their diabetes care. Responses were rated on a 7-point scale ranging from 1, "strongly disagree" to 7 "strongly agree". Responses are summed to create a total score with a range of 2 to 14. Higher numbers indicate greater satisfaction. | Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete support satisfaction data at both baseline and 6-months post-baseline. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline vs. 6 months |
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| Secondary | Patient Perception of SP Support: Supportive and Non-supportive Behaviors | Patient perception of support persons' (SP) supportive behaviors was assessed using the 8-item Important Other Climate Questionnaire (IOCQ) and non-supportive behaviors using 3 similarly-structured items addressing SP irritation, criticism and argumentativeness. All items are rated on a 7-point scale ranging from 0 ("strongly disagree") to 6 ("strongly agree"), with non-supportive behavior items being reversed scored. Item responses were averaged to create a mean score with a possible range of 0 (low support) to 6 (high support). | Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete IOCQ data at both baseline and 6-months post-baseline. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline vs. 6 months |
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| Secondary | Impact of COVID on Ability to Manage Diabetes | Impact of COVID on ability to manage Diabetes was assessed with a single closed-ended item: "In the last six months, how have the COVID pandemic or social distancing rules affected your ability to manage your diabetes?" The item is rated on a 5-point scale ranging from "much harder" to "much easier". Due to small numbers, the variable was collapsed to 3 categories for analysis: harder/much harder, no change, easier/much easier. | All patient participants with complete impact of COVID on diabetes management data. | Posted | Count of Participants | Participants | Cross-sectional at 6 months |
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| Secondary | Change in Diabetes Distress in Support Person | Support person distress about the patient's diabetes was assessed using the Problem Areas in Diabetes (PAID-5) Scale (for family members). The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items were summed to create a total score with a range of 0 to 20. A total score of >=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress. | Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 support persons enrolled in the study. Ns represent the number of support persons who had complete PAID-5 data at both baseline and 6-months post-baseline. See comments on Statistical Analysis 1 for additional detail. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline vs. 6 months |
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| Secondary | Change in Self-efficacy of Support Person | Support person self-efficacy for helping the patient with managing diabetes was assessed with the Self-Efficacy for Managing Chronic Diseases Scale (adapted for support persons). The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can help patients perform tasks related to their diabetes management (0, not at all confident to 10, very confident). Item responses are averaged, with mean scores ranging from 0 to 10. Higher numbers indicate greater self-efficacy. | Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 support persons enrolled in the study. Ns represent the number of support persons who had complete self-efficacy data at both baseline and 6-months post-baseline. See comments on Statistical Analysis 1 for additional detail. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline vs. 6 months |
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| Other Pre-specified | Change in Diabetes Self-care Behaviors in Patient: Healthy Eating | The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence. | Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete SDSCA diet data at both baseline and 12-months post-baseline. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline vs. 12 months |
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| Other Pre-specified | Change in Diabetes Self-care Behaviors in Patient: Physical Activity | The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence. | Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete SDSCA physical activity data at both baseline and 12-months post-baseline. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline vs. 12 months |
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| Other Pre-specified | Change in Diabetes Self-care Behaviors in Patient: Medication Adherence | The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence. Three types of medication adherence were assessed: number of days diabetes medications (non-insulin) were taken; number of days blood pressure medications were taken; number of days cholesterol medications were taken. Note that the Ns with data for these three measures are smaller than the Ns for diet and physical activity data. Differences are due to patients not having been prescribed non-insulin diabetes, blood pressure and/or cholesterol medications. | Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete adherence data for diabetes, blood pressure, and cholesterol medication, respectively, at both baseline and 12-months post-baseline. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline vs. 12 months |
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| Other Pre-specified | Change in Self-efficacy of Patient | Patient self-efficacy for managing diabetes was assessed with the Self-Efficacy for Managing Chronic Diseases Scale. The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can perform tasks related to their diabetes management (0, not at all confident to 10, very confident). Item responses are averaged, with mean scores ranging from 0 to 10. Higher numbers indicate greater self-efficacy. | Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete self-efficacy data at both baseline and 12-months post-baseline. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline vs. 12 months |
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| Other Pre-specified | Change in Patient Activation in Patient | Patient activation was assessed with the Patient Activation Measure (PAM)-10. Using a 4-point scale (1=strongly disagree to 4=strongly agree), respondents indicate the extent to which statements related to being ready, willing and able to manage their health and health care accurately describe them. Responses are summed to create a total score with higher numbers indicating greater activation. Item scale locations were transformed from the original logit metric to a user-friendly 0-100 metric where 0=the lowest possible activation and 100=the highest possible activation as measured by this set of items. While the metric allows for a potential range of 0-100, the items included in the measure only covered the range from 40 (minimum) to 60 (maximum), not tapping what would be theoretically the lowest or highest ranges of the construct. | Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete patient activation data at both baseline and 12-months post-baseline. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline vs. 12 months |
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| Other Pre-specified | Patient Perceived Overall Satisfaction With Support Person Support for Diabetes | Patient satisfaction with support person (SP) support for diabetes was assessed with 2* items assessing patient's satisfaction with the support they receive from their SP and whether they feel like they would be worse off without their SP's help with their diabetes care. Responses were rated on a 7-point scale ranging from 1, "strongly disagree" to 7 "strongly agree". Responses are summed to create a total score with a range of 2 to 14. Higher numbers indicate greater satisfaction. | Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete support satisfaction data at both baseline and 12-months post-baseline. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline vs. 12 months |
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| Other Pre-specified | Patient Perception of Support Person Support: Supportive and Non-supportive Behaviors | Patient perception of support persons' (SP) supportive behaviors was assessed using the 8-item Important Other Climate Questionnaire (IOCQ) and non-supportive behaviors using 3 similarly-structured items addressing SP irritation, criticism and argumentativeness. All items are rated on a 7-point scale ranging from 0 ("strongly disagree") to 6 ("strongly agree"), with non-supportive behavior items being reversed scored. Item responses were averaged to create a mean score with a possible range of 0 (low support) to 6 (high support). | Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete IOCQ data at both baseline and 12-months post-baseline. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline vs. 12 months |
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| Other Pre-specified | Change in Diabetes Distress in Support Person | Support person distress about the patient's diabetes was assessed using the Problem Areas in Diabetes (PAID-5) Scale (for family members). The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items were summed to create a total score with a range of 0 to 20. A total score of >=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress. | Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 support persons enrolled in the study. Ns represent the number of enrolled support persons who had complete PAID-5 data at both baseline and 12-months post-baseline. See comments on Statistical Analysis 1 for additional detail. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline vs. 12 months |
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| Other Pre-specified | Change in Self-efficacy of Support Person | Support person self-efficacy for helping the patient with managing diabetes was assessed with the Self-Efficacy for Managing Chronic Diseases Scale (adapted for support persons). The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can help patients perform tasks related to their diabetes management (0, not at all confident to 10, very confident). Item responses are averaged, with mean scores ranging from 0 to 10. Higher numbers indicate greater self-efficacy. | Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete self-efficacy data at both baseline and 12-months post-baseline.See comments on Statistical Analysis 1 for additional detail. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline vs. 12 months |
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| 0 |
| 112 |
| 18 |
| 112 |
| 38 |
| 112 |
| EG001 | I-DSMES-Patients | This arm will focus on the patient only. The Support Person assigned to this arm will not be invited to the introduction sessions, care management contacts, or diabetes self-management education sessions. Patients assigned to this arm will:
I-DSMES: Patient only will receive a Diabetes Complications Risk Assessment profile and introduction session, 4-6 group DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments. | 0 | 110 | 20 | 110 | 31 | 110 |
| EG002 | FAM-ACT-Support Persons | Patient and Support Person (dyad) will be included together as much as possible. The dyad will:
FAM ACT: Patient and Support Person (dyad) will receive a Diabetes Complications Risk Assessment profile and introduction session, Support Person-focused information/skills training through 4-6 extended DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments. | 0 | 112 | 0 | 112 | 0 | 112 |
| EG003 | I-DSMES-Support Persons | This arm will focus on the patient only. The Support Person assigned to this arm will not be invited to the introduction sessions, care management contacts, or diabetes self-management education sessions. Patients assigned to this arm will:
I-DSMES: Patient only will receive a Diabetes Complications Risk Assessment profile and introduction session, 4-6 group DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments. | 0 | 110 | 0 | 110 | 0 | 110 |
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| Blood clot | Vascular disorders | CTCAE (Unspecified) | Non-systematic Assessment | Blood clot requiring hospital admission. Unrelated to study participation. |
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| Pulmonary emphysema | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Non-systematic Assessment | Pulmonary emphysema exacerbation requiring hospital admission. Unrelated to study participation. |
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| Kidney pain | Renal and urinary disorders | CTCAE (Unspecified) | Non-systematic Assessment | Kidney pain requiring hospital admission. Unrelated to study participation. |
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| COVID-19 complications | Infections and infestations | CTCAE (Unspecified) | Non-systematic Assessment | COVID-19 complications requiring hospital admission. Unrelated to study participation. |
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| Hospital admission, unspecified | General disorders | CTCAE (Unspecified) | Non-systematic Assessment | Hospital admission unrelated to study participation with no additional information. |
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| Injury | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Non-systematic Assessment | Patient 1, finger laceration; patient 2, foot laceration; patient 3, puncture wound to foot; patient 4, fall. All resulted in a visit to a hospital emergency department without inpatient admission. None related to study participation. |
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| Shortness of breath | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Non-systematic Assessment | Shortness of breath resulting in a visit to a hospital emergency department. No inpatient admission. Unrelated to study participation. |
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| Fibromyalgia pain | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Non-systematic Assessment | Exacerbation of existing fibromyalgia pain resulting in a visit to a hospital emergency department. No inpatient admission. Unrelated to study participation. |
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| Emergency department, unspecified | General disorders | CTCAE (Unspecified) | Non-systematic Assessment | Unspecified events resulting in a visit to a hospital emergency department without inpatient admission. Unrelated to study participation. |
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Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Blood pressure medication |
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| Cholesterol medication |
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Change in patient blood pressure medication adherence (days/week meds were taken) was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c). Analyses were ITT and thus based on data from all enrolled patients. |
| Mixed Models Analysis |
| 0.94 |
| Mean Difference (Final Values) |
| -0.04 |
| 2-Sided |
| 95 |
| -0.98 |
| 0.91 |
Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES |
| Superiority |
| Change in patient cholesterol medication adherence (days/week meds were taken) was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c). Analyses were ITT and thus based on data from all enrolled patients. | Mixed Models Analysis | 0.42 | Mean Difference (Final Values) | -0.43 | 2-Sided | 95 | -1.46 | 0.61 | Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES | Superiority |
| Easier/much easier |
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| Superiority |
| Superiority |
| Blood pressure medications |
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| Cholesterol medications |
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Change in patient blood pressure medication adherence (days/week meds were taken) was analyzed in a manner similar to that described for the primary outcome (6month change in patient A1c). Analyses were ITT and thus based on data from all enrolled patients. |
| Mixed Models Analysis |
| 0.98 |
| Mean Difference (Final Values) |
| -0.01 |
| 2-Sided |
| 95 |
| -0.90 |
| 0.88 |
Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES |
| Superiority |
| Change in patient cholesterol medication adherence (days/week meds were taken) was analyzed in a manner similar to that described for the primary outcome (6month change in patient A1c). Analyses were ITT and thus based on data from all enrolled patients. | Mixed Models Analysis | 0.43 | Mean Difference (Final Values) | -0.41 | 2-Sided | 95 | -1.42 | 0.61 | Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES | Superiority |
Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT |