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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK140190-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| University of Alabama at Birmingham | OTHER |
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This behavioral clinical trial evaluates an adaptively tailored, mobile phone-delivered intervention (MOSAIC) designed to support adults managing their type 2 diabetes. Adaptive means the intervention can change over time. Tailored means the intervention may be different for different participants. The main questions the study will aim to answer are:
Participants will enroll in a 16-month study with assessments every 4 months. Assessments include completion of an A1c test and a survey. For those assigned to MOSAIC, they will experience 12-months of mobile phone-delivered support with 3 opportunities for intervention tailoring.
MOSAIC intervention components include:
PWD participants will be randomized in a parallel design to the MOSAIC adaptive mobile phone-delivered intervention or to print materials alone. The study is powered to detect a 0.5% reduction in hemoglobin A1c. Analyses will examine effects during the intervention (4 and 8 months) and post-intervention (12 months) and sustained effects (16 months). Participants will be analyzed as randomized regardless of withdrawal from the intervention (i.e., intention-to-treat principals) and missing data will be imputed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MOSAIC | Experimental | PWD participants will receive MOSAIC components (monthly phone coaching and text message support for goals and medication adherence) for 12 months. PWD participants will receive high-quality print materials upon enrollment and quarterly newsletters on healthy living with diabetes. All SP participants invited by PWD participants assigned to MOSAIC will receive high-quality print materials upon enrollment and quarterly newsletters on healthy living with diabetes. SPs may participate in monthly phone coaching and/or receive text message support tailored to the goal set by the linked PWD. |
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| Print Materials | Placebo Comparator | PWD 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 health living with diabetes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOSAIC | Behavioral | All MOSAIC PWD participants receive monthly phone coaching following a semi-structured protocol plus daily automated text message support. MOSAIC uses the mobile phone-delivered structure and functionality developed for FAMS (NCT04347291). Tailoring rules novel to MOSAIC determine phone coaching protocol content, text message content, and the involvement of a SP. Semi-structured protocols used in prior studies (and in the case of NCT04334109 adapted for mobile phone-delivery) are employed. Per tailoring rules, enrolled SPs may be invited to participate in monthly coaching calls with the PWD and/or receive text messages about supporting the PWD. The study will not assess outcomes or effects among SPs. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c During Intervention Period | Hemoglobin A1c assessed by mail-in A1c kits and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic management | Baseline and 4, 8, and 12 months post-baseline |
| Change in Hemoglobin A1c Sustained Post-intervention Effects | Hemoglobin A1c assessed by mail-in A1c kits and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic management | Baseline and 16 months post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diabetes Distress During Intervention Period | Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more emotional, psychological and social distress related to diabetes management (worse) | Baseline and 4, 8, and 12 months post-baseline |
| Change in Diabetes Distress Sustained Post-intervention Effect |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diabetes Self-efficacy (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 4, 8, 12, and 16 months post-baseline |
| Change in Diabetes Self-care Quality (Outcome & Mediator) |
Inclusion Criteria:
PERSONS WITH DIABETES:
SUPPORT PERSONS:
Exclusion Criteria:
PERSONS WITH DIABETES:
SUPPORT PERSONS:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Vanderbilt University Medical Center |
After study results are posted on clinical trials, de-identified individual and aggregate survey, clinical, and laboratory data (including raw and recoded data) and associated study documentation (survey codebook; analytic code used in survey and clinical data analyses; standard citation and unique identifier to facilitate attribution of data use) will be made publicly available through the Open Science Framework (OSF).
After study results are posted on clinical trials (required to occur within 1 year of final data collection), scientific data will be submitted to the Open Science Framework (OSF). Under the current repository policies, data will be preserved and available for the wider research community in perpetuity.
Survey, clinical, and laboratory data and associated study documentation (survey codebook; analytic code used in survey and clinical data analyses; standard citation and unique identifier to facilitate attribution of data use) will be shared and made publicly available through OSF as open access. Survey, clinical, and laboratory data will be made available in csv and text format and will not require the use of specialized tools to be accessed or manipulated. All shared data and documentation will be findable and identifiable using the standard data indexing tools in Open Science Framework.
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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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| ID | Term |
|---|---|
| D009030 | Mosaicism |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D002869 | Chromosome Aberrations |
| D009154 | Mutation |
| D014644 | Genetic Variation |
| D055614 | Genetic Phenomena |
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The labs analyzing A1c results (primary outcome, hemoglobin A1c) are masked to the study description or participants' assigned condition.
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| Print Materials | Behavioral | Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters |
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Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more emotional, psychological and social distress related to diabetes management (worse) |
| Baseline and 16 months post-baseline |
| Change in Psychosocial Well-being 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 4, 8, and 12 months post-baseline |
| Change in Psychosocial Well-being 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) | Baseline 16 months post-baseline |
Diabetes Self-Management Questionnaire - Revised (DSMQ-R) with scores ranging 0-10 with higher scores indicating more effective self-care behaviors (better) |
| Baseline and 4, 8, 12, and 16 months post-baseline |
| Change in Dietary Behavior (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) | Baseline and 4, 8, 12, and 16 months post-baseline |
| Change in Dietary Behavior (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 4, 8, 12, and 16 months post-baseline |
| Change in Physical Activity (Outcome & Mediator) | As assessed by the Physical Activity Scale for the Elderly (PASE) with scores ranging 0-400 where higher scores reflect greater levels of physical activity (better) | Baseline and 4, 8, 12, and 16 months post-baseline |
| Change in Physical Activity (Outcome & Mediator) | As assessed by the Exercise Vital Sign (EVS) with scores ranging 0-1,050 minutes per week of moderate to strenuous physical activity where higher scores indicate more physical activity (better) | Baseline and 4, 8, 12, and 16 months post-baseline |
| Change in Diabetes Medication Adherence (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 is better) | Baseline and 4, 8, 12, and 16 months post-baseline |
| Change in Diabetes Medication Adherence (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 4, 8, 12, and 16 months post-baseline |
| Nashville |
| Tennessee |
| 37203 |
| United States |
| D004700 | Endocrine System Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |