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This trial will compare two methods of increasing engagement in care and success in diabetes management, among patients with diabetes with high-risk features, who also have family members involved in their care.
Background:
Veterans with diabetes must control cardiovascular risk factors in order to prevent disabling and life-threatening complications. However, despite system wide advances in diabetes quality of care, over 30% of VHA patients with diabetes continue to have uncontrolled blood pressure, hyperglycemia, or hyperlipidemia. The nationwide VA PACT (Patient-Aligned Care Teams) initiative seeks to provide patients comprehensive, team-based support for following diabetes care regimens. PACT's success, however, hinges on its ability to effectively engage patients in care. One relatively untapped resource for supporting engagement in PACT is patients' family and friends. Three out of four adults with diabetes reach out to an unpaid family member or friend (a 'Care Partner') for ongoing help with diabetes management. These supporters help patients with medication adherence, tracking home glucose measurements, maintaining a healthy eating plan, and often accompany patients to their medical visits. However, while PACT emphasizes the importance of family members as part of the care team, PACT does not have formal mechanisms to involve health supporters in PACT care. Health supporters report that, in order to be more effective, they need more information on patient's medical care plans, clear channels for communicating with PACT team members, and information on navigating PACT resources.
Objectives:
The overall objective of this randomized trial is to test a strategy to strengthen the capacity of supporters to help patients with high-risk diabetes engage in PACT care and successfully enact care plans.
The central hypothesis is that providing health care engagement tools to both Care Partners and patients will increase patient activation and improve management of diabetes complication risks.
Methods:
This is a randomized controlled trial evaluating an intervention (Caring Others Increasing EngageMent in PACT, or CO-IMPACT) designed to structure and facilitate health supporter involvement in PACT so that patients can become more actively engaged in PACT care. 240 patients with diabetes receiving PACT primary care who: 1) are at high risk for diabetes complications due to hyperglycemia OR high blood pressure and 2) have a health supporter involved in their care will be recruited along with their health supporter. Patient-supporter dyads are randomized to the CO-IMPACT intervention or usual PACT care for high-risk diabetes, for 12 months.
The intervention provides patient-supporter dyads: one coaching session on action planning, communicating with providers, navigation skills and support skills; preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns. CO-IMPACT builds on medical record-integrated patient activation tools in the PACT toolkit and is designed to be implementable within existing PACT nurse encounters.
Primary outcomes for this study include a validated measure of patient activation (Patient Activation Measure-13) and a cardiac event 5-year risk score designed for patients with diabetes (UKPDS Risk Engine). Secondary outcomes include patients' self-efficacy for diabetes self-care; diabetes self-management behaviors including medication adherence; diabetes distress; and glycemic and blood pressure control. Measures among supporters include supporter activation, use of effective support techniques, distress about patient's diabetes care, and caregiver burden. We are also measuring patient-supporter and patient-provider relationship quality, patient safety (e.g. hypoglycemia), utilization, potential moderators of intervention effect such as patient health literacy level, and facilitators and barriers to wider implementation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CO-IMPACT | Experimental | patient and supporter (dyad) receive one coaching session on action planning, communicating with providers, navigation skills and support skills; preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns |
|
| PACT | Active Comparator | patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CO-IMPACT | Other | Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Activation, as Measured by Patient Activation Measure - 13 | Patient Activation Measure-13. Range of potential values (0,100), higher scores mean a better outcome, Outcome is the participant's difference in the measure between baseline and 12 months, among patient participants | Baseline to 12 months |
| Change in Cardiac Event 5-year Risk Score, as Measured by UKPDS Risk Engine | UKPDS Risk Engine, among patient participants only, range is 0 to 100% risk of cardiac event over the next 5 years. Lower score equals a better outcome. Outcome is the participant's difference in the measure between baseline and 12 months. | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diabetes Self-Management Behavior - Healthy Eating | Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values for healthy eating subscale (0 - 7 days per week), higher scores mean better outcomes, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diabetes Self-Efficacy | Adapted Stanford Chronic Disease self-efficacy scale, among patient participants. Range of potential values (1,10), higher score indicates higher self-efficacy. Outcome is the participant's difference in the measure between baseline and 12 months. | Baseline to 12 months |
| Change in Supporter Self-Efficacy for Helping With Diabetes Care |
Inclusion Criteria:
Patient Inclusion Criteria:
Care Partner Inclusion Criteria:
Exclusion Criteria:
Patient Exclusion Criteria:
Care Partner Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann-Marie Rosland, MD MS | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan | 48105 | United States | ||
| VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30041685 | Background | Rosland AM, Piette JD, Trivedi R, Kerr EA, Stoll S, Tremblay A, Heisler M. Engaging family supporters of adult patients with diabetes to improve clinical and patient-centered outcomes: study protocol for a randomized controlled trial. Trials. 2018 Jul 24;19(1):394. doi: 10.1186/s13063-018-2785-2. | |
| 34240285 | Result |
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Final dataset underlying publication resulting from this research will be shared upon request. Members of the scientific community can request a de-identified copy of the final dataset (i.e., dataset underlying any publication).
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Members of the scientific community should contact the PI. De-identified data may only be provided after requestors and data providers sign a standard federal agency Data Use Agreement.
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None. All patient-supporter dyads who enrolled in the study were randomized to one of two study arms.
Participants were recruited from 11/16/16 to 5/22/18. Eligible patient participants were identified from one of two participating VHA sites. Once identified, they received an introductory letter about the study and indicated interest by phone or mail.
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| ID | Title | Description |
|---|---|---|
| FG000 | CO-IMPACT | patient and supporter (dyad) receive one coaching session on action planning, communicating with providers, navigation skills and support skills; preparation by phone before patients? primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter |
| FG001 | PACT | patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits PACT: participants will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CO-IMPACT | patient and supporter (dyad) receive one coaching session on action planning, communicating with providers, navigation skills and support skills; preparation by phone before patients? primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Care Partner participant age was not collected in this study. Therefore median ages reflect only patient participants' median age. |
| 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 in Patient Activation, as Measured by Patient Activation Measure - 13 | Patient Activation Measure-13. Range of potential values (0,100), higher scores mean a better outcome, Outcome is the participant's difference in the measure between baseline and 12 months, among patient participants | This outcome was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 12 months |
|
Adverse event data were collected during the year participants were enrolled in the study. All participants participated between the dates of 01/03/17 to 06/03/19.
Definitions of adverse event and serious adverse event used by study team were consistent with the clinicaltrials.gov definitions. Adverse events were collected when self-reported by participants or family members when study staff reached out to schedule or conduct intervention components or assessment visits.
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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 | CO-IMPACT | patient and supporter (dyad) receive one coaching session on action planning, communicating with providers, navigation skills and support skills; preparation by phone before patients? primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Events | Cardiac disorders | Non-systematic Assessment | 3 patient participants (PT) had heart attacks; 1 PT in hospital for "heart issues"; 1 PT hospitalized CHF; 1 PT hospitalized arrythmia |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ann-Marie Rosland | VA Pittsburgh Healthcare System, Center for Health Equity Research and Promotion | 4123602259 | Ann-Marie.rosland@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 8, 2017 | May 18, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| 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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| PACT | Other | participants will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits |
|
| Change in Glycemic Control | Hemoglobin A1c, among patient participants. Common range is 4% to 14%, lower values indicate better outcomes. Outcome is the participant's difference in the measure between baseline and 12 months. | Baseline to 12 months |
| Change in Systolic Blood Pressure | mmHg, Average of two readings done at each time point. Common physiologic range is 80mmHg - 220mmHg. Lower values indicate better outcomes, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. | Baseline to 12 months |
| Change in Diabetes Distress | Problem Areas in Diabetes Scale (PAID) - range of potential values (0,20), higher scores indicate worse outcomes (greater diabetes-related emotional distress), among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. | Baseline to 12 months |
| Change in Activation in Health Encounters | Perceived Efficacy in Patient-Physician Interactions (PEPPI-5) - range of potential values (5, 25), higher scores indicate better outcomes (higher perceived self-efficacy in patient-physician interactions), among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. | Baseline to 12 months |
| Change in Non-Fasting Lipid Levels | Total cholesterol mg/DL to HDL mg/DL Ratio, common range is 1-10, lower values indicate better outcomes, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. | Baseline to 12 months |
| Change in Patient Satisfaction With Healthcare System Support for Family Supporter | Measured as percent of patient participants answering they were 'very satisfied' or 'satisfied' with healthcare system support for their Care Partner (family supporter)'s participation in their healthcare. Response options were 'very unsatisfied', 'unsatisfied', 'neither', 'satisfied', or 'very satisfied'. Increase in proportion of 'very satisfied' or 'satisfied' indicates better outcomes (higher satisfaction), among patient participants. | Baseline to 12 months |
| Change in Supporter Use of Autonomy-Supportive Communication | Important Other Climate Questionnaire (IOCQ) - patient rating of supporter communication. Range of potential values (1,7), higher scores indicate better outcomes (higher patient perception of supporter use of autonomy supportive communication), among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. | Baseline to 12 months |
| Change in Smoking Status | Global Adult Tobacco Survey, values include 'current smoker', 'former smoker', or 'never smoker'. Change from current to former smoker over 12 months indicates a better outcome. Measured among patient participants. | Baseline to 12 months |
| Change in Diabetes Self-Management Behavior - Physical Activity | Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values for physical activity subscale (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. | Baseline to 12 months |
| Change in Diabetes Self-Management Behavior - Blood Sugar Home Testing | Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. | Baseline to 12 months |
| Change in Diabetes Self-Management Behavior - Blood Pressure Home Testing | Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. | Baseline to 12 months |
| Change in Diabetes Self-Management Behavior - Take Oral Meds as Prescribed | Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. | Baseline to 12 months |
| Change in Diabetes Self-Management Behavior - Take Insulin as Prescribed | Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. | Baseline to 12 months |
| Change in Diabetes Self-Management Behavior - Check Feet | Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. | Baseline to 12 months |
Adapted Stanford Chronic Disease self-efficacy scale, among family supporter participants. Range of potential values (1,10), higher score indicates higher self-efficacy. Outcome is the participant's difference in the measure between baseline and 12 months. |
| Baseline to 12 months |
| Change in Caregiver Burden | Caregiver Strain Index - range of potential values (0,13), higher scores (7 or more) mean worse outcomes, among family supporter participants. Outcome is the participant's difference in the measure between baseline and 12 months. | Baseline to 12 months |
| Change in Supporter Distress About Patient Participant's Diabetes | Adapted Problem Areas In Diabetes Scale (PAID) - range of potential values (0,20), higher scores indicate worse outcomes (greater diabetes-related emotional distress), among family supporter participants. Outcome is the participant's difference in the measure between baseline and 12 months. | Baseline to 12 months |
| Pittsburgh |
| Pennsylvania |
| 15240 |
| United States |
| Zupa MF, Lee A, Piette JD, Trivedi R, Youk A, Heisler M, Rosland AM. Impact of a Dyadic Intervention on Family Supporter Involvement in Helping Adults Manage Type 2 Diabetes. J Gen Intern Med. 2022 Mar;37(4):761-768. doi: 10.1007/s11606-021-06946-8. Epub 2021 Jul 8. |
| 36374502 | Derived | Rosland AM, Piette JD, Trivedi R, Lee A, Stoll S, Youk AO, Obrosky DS, Deverts D, Kerr EA, Heisler M. Effectiveness of a Health Coaching Intervention for Patient-Family Dyads to Improve Outcomes Among Adults With Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2237960. doi: 10.1001/jamanetworkopen.2022.37960. |
| Lost to Follow-up |
|
| BG001 | PACT | patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits PACT: participants will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits |
| BG002 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| years |
|
| Sex: Female, Male | Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Insulin Use among Patient Participants | Insulin Use was only collected for patient participants, but not their care partners. | Count of Participants | Participants |
|
| PAM-13 Cutoff | (Patient Activation Measure-13) - theoretical range of potential values (0,100), higher scores mean a better outcome, mean is computed for the difference in PAM scores from baseline to twelve months, among patient participants | Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116. | Count of Participants | Participants |
|
| Care Partner Lives with Patient Participant | This measure is specific to the care partners only. | Count of Participants | Participants |
|
| Patient Baseline Patient Activation Measure (PAM-13) | (Patient Activation Measure-13) - theoretical range of potential values (0,100), higher scores mean a better outcome, mean score is computed at baseline among patient participants | This measure includes data from Patient Participants only | Mean | Standard Deviation | units on a scale |
|
| Baseline UKPDS 5-Year Cardiac Risk Score | United Kingdom Prospective Diabetes Study Risk Engine, among patient participants only, theoretical range is 0 to 100%, lower score equals a lower likelihood of an acute cardiac event over the next 5 years. Scores incorporate the individuals' level of HbA1c, blood pressure, cholesterol, and smoking status. Mean is computed at baseline among patient participants. | UKPDS Score only assessed among patient participants. | Mean | Standard Deviation | units on a scale |
|
| Enrolled at Hospital-based clinic (vs. community clinic site) | This measure is only among patient participants. | Count of Participants | Participants |
|
| OG001 | PACT | patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits. |
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| Primary | Change in Cardiac Event 5-year Risk Score, as Measured by UKPDS Risk Engine | UKPDS Risk Engine, among patient participants only, range is 0 to 100% risk of cardiac event over the next 5 years. Lower score equals a better outcome. Outcome is the participant's difference in the measure between baseline and 12 months. | This outcome was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 12 months |
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| Secondary | Change in Diabetes Self-Management Behavior - Healthy Eating | Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values for healthy eating subscale (0 - 7 days per week), higher scores mean better outcomes, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. | The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 months |
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| Secondary | Change in Glycemic Control | Hemoglobin A1c, among patient participants. Common range is 4% to 14%, lower values indicate better outcomes. Outcome is the participant's difference in the measure between baseline and 12 months. | The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis. | Posted | Mean | Standard Deviation | percent of glycosylated hemoglobin | Baseline to 12 months |
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| Secondary | Change in Systolic Blood Pressure | mmHg, Average of two readings done at each time point. Common physiologic range is 80mmHg - 220mmHg. Lower values indicate better outcomes, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. | The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis. | Posted | Mean | Standard Deviation | mmHg | Baseline to 12 months |
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| Secondary | Change in Diabetes Distress | Problem Areas in Diabetes Scale (PAID) - range of potential values (0,20), higher scores indicate worse outcomes (greater diabetes-related emotional distress), among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. | The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 months |
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| Secondary | Change in Activation in Health Encounters | Perceived Efficacy in Patient-Physician Interactions (PEPPI-5) - range of potential values (5, 25), higher scores indicate better outcomes (higher perceived self-efficacy in patient-physician interactions), among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. | The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 months |
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| Secondary | Change in Non-Fasting Lipid Levels | Total cholesterol mg/DL to HDL mg/DL Ratio, common range is 1-10, lower values indicate better outcomes, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. | The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis. | Posted | Mean | Standard Deviation | mg/dL | Baseline to 12 months |
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| Secondary | Change in Patient Satisfaction With Healthcare System Support for Family Supporter | Measured as percent of patient participants answering they were 'very satisfied' or 'satisfied' with healthcare system support for their Care Partner (family supporter)'s participation in their healthcare. Response options were 'very unsatisfied', 'unsatisfied', 'neither', 'satisfied', or 'very satisfied'. Increase in proportion of 'very satisfied' or 'satisfied' indicates better outcomes (higher satisfaction), among patient participants. | The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis. | Posted | Count of Participants | Participants | Baseline to 12 months |
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| Secondary | Change in Supporter Use of Autonomy-Supportive Communication | Important Other Climate Questionnaire (IOCQ) - patient rating of supporter communication. Range of potential values (1,7), higher scores indicate better outcomes (higher patient perception of supporter use of autonomy supportive communication), among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. | The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 months |
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| Secondary | Change in Smoking Status | Global Adult Tobacco Survey, values include 'current smoker', 'former smoker', or 'never smoker'. Change from current to former smoker over 12 months indicates a better outcome. Measured among patient participants. | The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis. | Posted | Count of Participants | Participants | Baseline to 12 months |
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| Secondary | Change in Diabetes Self-Management Behavior - Physical Activity | Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values for physical activity subscale (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. | The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 months |
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| Secondary | Change in Diabetes Self-Management Behavior - Blood Sugar Home Testing | Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. | The outcome was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 months |
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| Secondary | Change in Diabetes Self-Management Behavior - Blood Pressure Home Testing | Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. | This outcome was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 months |
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| Secondary | Change in Diabetes Self-Management Behavior - Take Oral Meds as Prescribed | Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. | The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 months |
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| Secondary | Change in Diabetes Self-Management Behavior - Take Insulin as Prescribed | Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. | The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 months |
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| Secondary | Change in Diabetes Self-Management Behavior - Check Feet | Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. | The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 months |
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| Other Pre-specified | Change in Diabetes Self-Efficacy | Adapted Stanford Chronic Disease self-efficacy scale, among patient participants. Range of potential values (1,10), higher score indicates higher self-efficacy. Outcome is the participant's difference in the measure between baseline and 12 months. | The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 months |
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| Other Pre-specified | Change in Supporter Self-Efficacy for Helping With Diabetes Care | Adapted Stanford Chronic Disease self-efficacy scale, among family supporter participants. Range of potential values (1,10), higher score indicates higher self-efficacy. Outcome is the participant's difference in the measure between baseline and 12 months. | The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 months |
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| Other Pre-specified | Change in Caregiver Burden | Caregiver Strain Index - range of potential values (0,13), higher scores (7 or more) mean worse outcomes, among family supporter participants. Outcome is the participant's difference in the measure between baseline and 12 months. | The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 months |
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| Other Pre-specified | Change in Supporter Distress About Patient Participant's Diabetes | Adapted Problem Areas In Diabetes Scale (PAID) - range of potential values (0,20), higher scores indicate worse outcomes (greater diabetes-related emotional distress), among family supporter participants. Outcome is the participant's difference in the measure between baseline and 12 months. | The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 months |
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| 2 |
| 246 |
| 29 |
| 246 |
| 0 |
| 246 |
| EG001 | PACT | patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits PACT: participants will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits | 1 | 232 | 2 | 232 | 0 | 232 |
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| Vascular Issues | Vascular disorders | Non-systematic Assessment | 2 patient participants (PT) hospitalized for high blood pressure (1 intervention, 1 control); 1 PT hospitalized low blood pressure; 1 PT in emergency room for blood clot |
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| Infection | Infections and infestations | Non-systematic Assessment | 1 patient participant (PT) hospitalized due to infection; 1 PT hospitalized for sepsis; 1 PT eye infection; 1 PT sinus infection. |
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| Surgeries | Surgical and medical procedures | Non-systematic Assessment | 2 patient participants (PT) had lower limb amputations; 1 PT hand injury & surgery; 1 PT emergency intestinal surgery |
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| Injury | Injury, poisoning and procedural complications | Non-systematic Assessment | 1 patient participant (PT) broken bone in lower limb; 1 PT car accident; 2 PTs broken bones or dislocations upper limbs |
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| Stroke | Nervous system disorders | Non-systematic Assessment | 4 patient participants (PT) had strokes, all withdrew. 2 PT hospitalized for passing out, one had renal failure also; 1 PT in and out of hospital since stroke; 1 PT withdrawn by Care partner because not cognitively present |
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| General Diagnoses, Hospitalizations | General disorders | Non-systematic Assessment | 1 Control patient participant (PT) admitted to hospital (no reason provided ; 1 PT diagnosed cancer |
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| Social Circumstances | Social circumstances | Non-systematic Assessment | 1 PT lost housing |
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| Multiple Issues | General disorders | Non-systematic Assessment | One Patient participant had a stroke, kidney stones |
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Not provided
Not provided
Not provided
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| Male |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Superiority |
| No change |
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| Superiority |
| Superiority |
| Superiority |
| Superiority |
Net difference defined as 12 months minus baseline |
| Superiority |