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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK119282 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This study evaluates a mobile phone-delivered intervention (FAMS 2.0; Family/friend Activation to Motivate Self-care) designed to help adults with type 2 diabetes set and achieve self-care goals and improve the quality of family/friend support for their goals. The investigators hypothesize that FAMS 2.0 will improve glycemic control and reduce diabetes distress among patients and reduce support burden and diabetes distress in enrolled support persons. The investigators hypothesize the mechanisms by which FAMS 2.0 will affect these outcomes for the patient include (a) increased helpful and reduced harmful family/friend involvement, (b) increased self-care (i.e., diet, physical activity, medication adherence), and (c) increased diabetes self-efficacy.
The 9-month FAMS 2.0 intervention is an expansion and improvement of a previously evaluated intervention (FAMS; NCT02481596). FAMS components include:
Participants will be randomized in a parallel design to either FAMS 2.0 or an active control. Our target enrollment is N=334 dyads (patient participants and support persons). Patients are encouraged to invite a support person, but it is not required. Patients and their support person will be randomized together (if enrolled). The study is powered to detect a 0.5% reduction in hemoglobin A1c. Analyses will examine effects at 9 months (post-intervention) and 15 months (sustained effects). The investigators will impute missing data, including all participants completing at least two data collection periods in analyses. Participants will be analyzed as randomized regardless of withdrawal from the intervention (i.e., intention-to-treat principals).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FAMS 2.0 | Experimental | Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. |
|
| Print Materials | Placebo Comparator | All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAMS 2.0 | Behavioral | FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycemic Control (Patient Participants) During Intervention Period | Hemoglobin A1c assessed by mail-in A1c kits from CoreMedica and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic control | Baseline and 6 and 9 months post-baseline |
| Change in Glycemic Control (Patient Participants) Sustained Post-intervention Effects | Hemoglobin A1c assessed by mail-in A1c kits from CoreMedica and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic control | Baseline and 12 and 15 months post-baseline |
| Change in Diabetes Distress (Patient Participants) During Intervention Period | Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more distress (worse) | Baseline and 6 and 9 months post-baseline |
| Change in Diabetes Distress (Patient Participants) Sustained Post-intervention Effect | Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more distress (worse) | Baseline and 15 months post-baseline |
| Change in Psychosocial Well-being (Patient Participants) During Intervention Period | Assessed by the World Health Organization - Five Well-Being Index (WHO-5) with scores ranging 0 to 100 where higher scores indicate more well-being (better) | Baseline and 6 and 9 months post-baseline |
| Change in Psychosocial Well-being (Patient Participants) Sustained Post-intervention Effect |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diabetes Distress (Support Person Participants) During Intervention Period | as assessed by the Problem Areas in Diabetes (PAID-5) Family Member Version. Scores range 0-100 where higher scores indicate more diabetes distress experienced by the support person (worse) | Baseline and 6 and 9 months post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diabetes Self-efficacy (Patient Participants - Outcome & Mediator) | as assessed by the Perceived Diabetes Self-Management Scale with scores ranging 8 to 40 with higher scores indicating more self-efficacy (better) | Baseline and 6 and 9 months post-baseline |
| Change in Dietary Behavior (Patient Participants - Outcome & Mediator) |
Inclusion Criteria:
PATIENTS:
SUPPORT PERSONS:
Exclusion Criteria:
PATIENTS:
SUPPORT PERSONS:
- Demonstrates inability to receive and respond to a text
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39661957 | Derived | Roddy MK, Spieker AJ, Greevy RA Jr, Nelson LA, Berg C, Mayberry LS. Diabetes-specific family functioning typology associated with intervention engagement and effects: secondary analyses from a randomized controlled trial. Ann Behav Med. 2025 Jan 4;59(1):kaae070. doi: 10.1093/abm/kaae070. | |
| 38297891 | Derived | Nelson LA, Spieker AJ, LeStourgeon LM, Greevy RA Jr, Molli S, Roddy MK, Mayberry LS. The Goldilocks Dilemma on Balancing User Response and Reflection in mHealth Interventions: Observational Study. JMIR Mhealth Uhealth. 2024 Jan 19;12:e47632. doi: 10.2196/47632. |
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After study results are posted on clinical trials and published, de-identified data will be available upon requests made to the principal investigator.
After study results are posted on clinical trials and outcomes published in a peer-reviewed journal, until 5 years later.
Contact the principal investigator
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9 patient participants were administratively withdrawn prior to randomization; 6 of those participants also had a support person enrolled who was administratively withdrawn. These patient participants were unreachable during a pre-determined run-in period after enrollment and therefore withdrawn per protocol.
We recruited patient participants with a goal of 334 enrolled. Patient participants could invite a support person to enroll with them, but this was not required. 638 represents 338 patient participants and 300 support persons.
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| ID | Title | Description |
|---|---|---|
| FG000 | FAMS 2.0 | Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. FAMS 2.0: FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters. |
| FG001 | Print Materials | All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patient participants had the option to invite a support person, but support person participation was not required. Patient participants were randomized with their support person (if enrolled). There were 329 patient participants and 294 support persons (294 patient/support person dyads; 35 patients participated without a support person).
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| ID | Title | Description |
|---|---|---|
| BG000 | FAMS 2.0 | Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. FAMS 2.0: FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Patient participants were randomized with their support person (if enrolled). There were 329 patient participants and 294 support persons (294 patient/support person dyads; 35 patients participated without a support person). |
| 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 Glycemic Control (Patient Participants) During Intervention Period | Hemoglobin A1c assessed by mail-in A1c kits from CoreMedica and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic control | Patient participants | Posted | Mean | Standard Deviation | percent | Baseline and 6 and 9 months post-baseline |
|
We followed participants for 15 months of study participation, with the first participant enrollment in April 2020 until the last participant completed 15-month follow-up in February 2023.
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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 | FAMS 2.0-Patient Participants | Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. FAMS 2.0: FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lindsay Mayberry | Vanderbilt University Medical Center | 615-875-5821 | lindsay.mayberry@vumc.org |
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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 | Oct 24, 2021 | Aug 22, 2023 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 20, 2023 | Nov 20, 2023 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 25, 2021 | Mar 16, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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The investigators use mail-in A1c kits for the primary outcome - hemoglobin A1c - and the lab analyzing these samples is masked to study description or participants' assigned condition.
|
| Print Materials | Behavioral | Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters. |
|
Assessed by the World Health Organization - Five Well-Being Index (WHO-5) with scores ranging 0 to 100 where higher scores indicate more well-being (better)
| Baseline and15 months post-baseline |
| Change in Diabetes Distress (Support Person Participants) Sustained Post-intervention Effect |
Assessed by the Problem Areas in Diabetes (PAID-5) Family Member Version. Scores range 0-100 with higher scores indicate more diabetes distress experienced by the support person (worse) |
| Baseline and 15 months post-baseline |
| Change in Support Burden (Support Person Participants) During Intervention Period | as assessed by the Impact of Diabetes Profile-Family Members from the Diabetes Attitudes Wishes and Needs Study-2 (DAWN2). Scores range 0 to 4 where higher scores indicate greater support burden (worse) | Baseline and 6 and 9 months post-baseline |
| Change in Support Burden (Support Person Participants) Sustained Post-intervention Effect | as assessed by the Impact of Diabetes Profile-Family Members from the Diabetes Attitudes Wishes and Needs Study-2 (DAWN2). Scores range 0 to 100 where higher scores indicate greater support burden (worse) | Baseline and 15 months post-baseline |
as assessed by Personal Diabetes Questionnaire, Use of Information for Decision Making Scale with scores ranging 1-6 where higher scores indicate more use of dietary information for decision making (better) |
| Baseline and 6, 9, and 15 months post-baseline |
| Change in Dietary Behavior (Patient Participants - Outcome & Mediator) | as assessed by Personal Diabetes Questionnaire, Problem Eating Behavior scale with scores ranging 1-6 where higher scores indicate more problem eating behaviors (worse) | Baseline and 6, 9, and 15 months post-baseline |
| Change in Physical Activity (Patient Participants - Outcome & Mediator) | as assessed by a modified Rapid Assessment of Physical Activity with scores ranging 0 to 6533 with higher scores indicating more physical activity (better) | Baseline and 6, 9, and 15 months post-baseline |
| Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) | as assessed by the Summary of Diabetes Self-Care Activities medications subscale with scores ranging 0 to 7 representing days in the prior week with perfect adherence (higher better) | Baseline and 6, 9, and 15 months post-baseline |
| Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) | as assessed by the Adherence to Refills and Medications in Diabetes scale, with scores ranging 11-44 with higher scores indicating more problems with adherence (worse) | Baseline and 6, 9, and 15 months post-baseline |
| Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | as assessed by the Helpful Involvement scale of Family/friend Involvement in Adults' Diabetes with scores ranging 1 to 5 with higher scores indicating more helpful involvement (better) | Baseline and 6, 9, and 15 months post-baseline |
| Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | as assessed by the Important Others Climate Questionnaire, specific to diabetes management, with scores ranging 1 to 5 with higher scores indicating more autonomy supportive communication (better) | Baseline and 6, 9, and 15 months post-baseline |
| Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | as assessed by the Harmful Involvement scale of Family/friend Involvement in Adults' Diabetes with scores ranging 1 to 5 with higher scores indicating more harmful involvement (worse) | Baseline and 6, 9, and 15 months post-baseline |
| Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | as assessed by the criticism items from the Family Emotional Involvement and Criticism Scale, specific to diabetes management, with scores ranging 0 to 16 with higher scores indicating more perceived criticism (worse) | Baseline and 6, 9, and 15 months post-baseline |
| Change in Helpful Support Person Involvement (Support Person Participants - Outcome & Mediator) | as assessed by the Helpful Involvement scale of Family/friend Involvement in Adults' Diabetes - support person version. Scores ranging 1 to 5 with higher scores indicating more helpful involvement (better) | Baseline and 6, 9, and 15 months post-baseline |
| Change in Harmful Support Person Involvement (Support Person Participants - Outcome & Mediator) | as assessed by the Harmful Involvement scale of Family/friend Involvement in Adults' Diabetes - support person version. Scores ranging 1 to 5 with higher scores indicating more harmful involvement (worse) | Baseline and 6, 9, and 15 months post-baseline |
| Change in Support Person Involvement Alignment (Support Person Participants - Outcome & Mediator) | as assessed by items from the Family Experience of Patient Involvement measure from the Diabetes Attitudes Wishes and Needs Study-2 (DAWN2). Scores range 0 to 4 where a score of 2 indicates alignment between the support person's current level of involvement and their desired level of involvement. We will report change in the % aligned (reporting a 2) across conditions. | Baseline and 6, 9, and 15 months post-baseline |
| 37750180 | Derived | Roddy MK, El-Rifai M, LeStourgeon L, Aikens JE, Wolever RQ, Greevy RA, Mayberry LS. Prerandomization withdrawals from a Type 2 diabetes self-care support intervention trial are associated with lack of available support person coparticipant. Chronic Illn. 2025 Mar;21(1):105-114. doi: 10.1177/17423953231203734. Epub 2023 Sep 26. |
| 36208719 | Derived | Mayberry LS, El-Rifai M, Nelson LA, Parks M, Greevy RA Jr, LeStourgeon L, Molli S, Bergner E, Spieker A, Aikens JE, Wolever RQ. Rationale, design, and recruitment outcomes for the Family/Friend Activation to Motivate Self-care (FAMS) 2.0 randomized controlled trial among adults with type 2 diabetes and their support persons. Contemp Clin Trials. 2022 Nov;122:106956. doi: 10.1016/j.cct.2022.106956. Epub 2022 Oct 5. |
| BG001 | Print Materials | All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | Patient participants were randomized with their support person (if enrolled). There were 329 patient participants and 294 support persons (294 patient/support person dyads; 35 patients participated without a support person).. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Patient participants were randomized with their support person (if enrolled). There were 329 patient participants and 294 support persons (294 patient/support person dyads; 35 patients participated without a support person). | Count of Participants | Participants |
|
| Race (NIH/OMB) | Patient participants were randomized with their support person (if enrolled). There were 329 patient participants and 294 support persons (294 patient/support person dyads; 35 patients participated without a support person). | Count of Participants | Participants |
|
| Hemoglobin A1c (patient participants) | Hemoglobin A1c assessed by mail-in A1c kits from CoreMedica and/or taken from electronic health record (venipuncture or point-of-care) | Hemoglobin A1c data was collected from patient participants (n=329) and used in the analysis of the primary outcome measure. | Mean | Standard Deviation | percent |
|
| Diabetes distress (patient participants) | as assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more distress (worse) | Patient participants' diabetes distress was assessed at baseline and used in the analysis of the primary outcome measure. There were 329 patient participants. | Mean | Standard Deviation | score on a scale |
|
| Psychosocial well-being (patient participants) | as assessed by the World Health Organization - Five Well-Being Index (WHO-5) with scores ranging 0 to 100 where higher scores indicate more well-being (better) | Patient participants' psychosocial well-being was assessed at baseline and used in the analysis of the primary outcome measure. There were 329 patient participants. | Mean | Standard Deviation | score on a scale |
|
| OG001 | Print Materials | All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters. |
|
|
| Primary | Change in Glycemic Control (Patient Participants) Sustained Post-intervention Effects | Hemoglobin A1c assessed by mail-in A1c kits from CoreMedica and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic control | Patient participants | Posted | Mean | Standard Deviation | percent | Baseline and 12 and 15 months post-baseline |
|
|
|
| Primary | Change in Diabetes Distress (Patient Participants) During Intervention Period | Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more distress (worse) | Patient participants | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 and 9 months post-baseline |
|
|
|
| Primary | Change in Diabetes Distress (Patient Participants) Sustained Post-intervention Effect | Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more distress (worse) | Patient participants | Posted | Mean | Standard Deviation | score on a scale | Baseline and 15 months post-baseline |
|
|
|
| Primary | Change in Psychosocial Well-being (Patient Participants) During Intervention Period | Assessed by the World Health Organization - Five Well-Being Index (WHO-5) with scores ranging 0 to 100 where higher scores indicate more well-being (better) | Patient participants | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 and 9 months post-baseline |
|
|
|
| Primary | Change in Psychosocial Well-being (Patient Participants) Sustained Post-intervention Effect | Assessed by the World Health Organization - Five Well-Being Index (WHO-5) with scores ranging 0 to 100 where higher scores indicate more well-being (better) | Patient participants | Posted | Mean | Standard Deviation | score on a scale | Baseline and15 months post-baseline |
|
|
|
| Secondary | Change in Diabetes Distress (Support Person Participants) During Intervention Period | as assessed by the Problem Areas in Diabetes (PAID-5) Family Member Version. Scores range 0-100 where higher scores indicate more diabetes distress experienced by the support person (worse) | Support person participants | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 and 9 months post-baseline |
|
|
|
| Secondary | Change in Diabetes Distress (Support Person Participants) Sustained Post-intervention Effect | Assessed by the Problem Areas in Diabetes (PAID-5) Family Member Version. Scores range 0-100 with higher scores indicate more diabetes distress experienced by the support person (worse) | Support person participants | Posted | Mean | Standard Deviation | score on a scale | Baseline and 15 months post-baseline |
|
|
|
| Secondary | Change in Support Burden (Support Person Participants) During Intervention Period | as assessed by the Impact of Diabetes Profile-Family Members from the Diabetes Attitudes Wishes and Needs Study-2 (DAWN2). Scores range 0 to 4 where higher scores indicate greater support burden (worse) | Support person participants | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 and 9 months post-baseline |
|
|
|
| Secondary | Change in Support Burden (Support Person Participants) Sustained Post-intervention Effect | as assessed by the Impact of Diabetes Profile-Family Members from the Diabetes Attitudes Wishes and Needs Study-2 (DAWN2). Scores range 0 to 100 where higher scores indicate greater support burden (worse) | Support person participants | Posted | Mean | Standard Deviation | score on a scale | Baseline and 15 months post-baseline |
|
|
|
| Other Pre-specified | Change in Diabetes Self-efficacy (Patient Participants - Outcome & Mediator) | as assessed by the Perceived Diabetes Self-Management Scale with scores ranging 8 to 40 with higher scores indicating more self-efficacy (better) | Patient participants | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 and 9 months post-baseline |
|
|
|
| Other Pre-specified | Change in Dietary Behavior (Patient Participants - Outcome & Mediator) | as assessed by Personal Diabetes Questionnaire, Use of Information for Decision Making Scale with scores ranging 1-6 where higher scores indicate more use of dietary information for decision making (better) | Patient participants | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6, 9, and 15 months post-baseline |
|
|
|
| Other Pre-specified | Change in Dietary Behavior (Patient Participants - Outcome & Mediator) | as assessed by Personal Diabetes Questionnaire, Problem Eating Behavior scale with scores ranging 1-6 where higher scores indicate more problem eating behaviors (worse) | Patient participants | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6, 9, and 15 months post-baseline |
|
|
|
| Other Pre-specified | Change in Physical Activity (Patient Participants - Outcome & Mediator) | as assessed by a modified Rapid Assessment of Physical Activity with scores ranging 0 to 6533 with higher scores indicating more physical activity (better) | Patient participants | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6, 9, and 15 months post-baseline |
|
|
|
| Other Pre-specified | Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) | as assessed by the Summary of Diabetes Self-Care Activities medications subscale with scores ranging 0 to 7 representing days in the prior week with perfect adherence (higher better) | Patient participants | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6, 9, and 15 months post-baseline |
|
|
|
| Other Pre-specified | Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) | as assessed by the Adherence to Refills and Medications in Diabetes scale, with scores ranging 11-44 with higher scores indicating more problems with adherence (worse) | Patient participants | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6, 9, and 15 months post-baseline |
|
|
|
| Other Pre-specified | Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | as assessed by the Helpful Involvement scale of Family/friend Involvement in Adults' Diabetes with scores ranging 1 to 5 with higher scores indicating more helpful involvement (better) | Patient participants | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6, 9, and 15 months post-baseline |
|
|
|
| Other Pre-specified | Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | as assessed by the Important Others Climate Questionnaire, specific to diabetes management, with scores ranging 1 to 5 with higher scores indicating more autonomy supportive communication (better) | Patient participants | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6, 9, and 15 months post-baseline |
|
|
|
| Other Pre-specified | Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | as assessed by the Harmful Involvement scale of Family/friend Involvement in Adults' Diabetes with scores ranging 1 to 5 with higher scores indicating more harmful involvement (worse) | Patient participants | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6, 9, and 15 months post-baseline |
|
|
|
| Other Pre-specified | Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | as assessed by the criticism items from the Family Emotional Involvement and Criticism Scale, specific to diabetes management, with scores ranging 0 to 16 with higher scores indicating more perceived criticism (worse) | Patient participants | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6, 9, and 15 months post-baseline |
|
|
|
| Other Pre-specified | Change in Helpful Support Person Involvement (Support Person Participants - Outcome & Mediator) | as assessed by the Helpful Involvement scale of Family/friend Involvement in Adults' Diabetes - support person version. Scores ranging 1 to 5 with higher scores indicating more helpful involvement (better) | Support person participants | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6, 9, and 15 months post-baseline |
|
|
|
| Other Pre-specified | Change in Harmful Support Person Involvement (Support Person Participants - Outcome & Mediator) | as assessed by the Harmful Involvement scale of Family/friend Involvement in Adults' Diabetes - support person version. Scores ranging 1 to 5 with higher scores indicating more harmful involvement (worse) | Support person participants | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6, 9, and 15 months post-baseline |
|
|
|
| Other Pre-specified | Change in Support Person Involvement Alignment (Support Person Participants - Outcome & Mediator) | as assessed by items from the Family Experience of Patient Involvement measure from the Diabetes Attitudes Wishes and Needs Study-2 (DAWN2). Scores range 0 to 4 where a score of 2 indicates alignment between the support person's current level of involvement and their desired level of involvement. We will report change in the % aligned (reporting a 2) across conditions. | Support person participants | Posted | Count of Participants | Participants | Baseline and 6, 9, and 15 months post-baseline |
|
|
|
| 1 |
| 164 |
| 0 |
| 164 |
| 0 |
| 164 |
| EG001 | FAMS 2.0-Support Persons | Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. FAMS 2.0: FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters. | 0 | 150 | 0 | 150 | 0 | 150 |
| EG002 | Print Materials-Patient Participants | All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters. | 2 | 165 | 0 | 165 | 0 | 165 |
| EG003 | Print Materials-Support Persons | All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters. | 0 | 144 | 0 | 144 | 0 | 144 |
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| Prefer to self-describe |
|
| Unknown or not reported |
|
| Female |
|
| Prefer to self-describe |
|
| Unknown or not reported |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 15 months |
|
| 9 months |
|
| 9 months |
|
| 9 months |
|
| 9 months |
|
| 9 months |
|
| 9 months |
|
| 15 months |
|
| 9 months |
|
| 15 months |
|
| 9 months |
|
| 15 months |
|
| 9 months |
|
| 15 months |
|
| 9 months |
|
| 15 months |
|
| 9 months |
|
| 15 months |
|
| 9 months |
|
| 15 months |
|
| 9 months |
|
| 15 months |
|
| 9 months |
|
| 15 months |
|
| 9 months |
|
| 15 months |
|
| 9 months |
|
| 15 months |
|
| 9 months |
|
| 15 months |
|