Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K23DK140531 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
Not provided
This is a pilot and feasibility study for a mobile phone-delivered intervention, called STRIDE (STrong Relationships to Improve DiabEtes), designed to provide support for adults with type 2 diabetes (improve glycemic management and social support). The goal of the study is to examine the feasibility and acceptability of STRIDE.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Step 1: Optimal First Line Treatment | Experimental | Persons with diabetes (PWD) participants will first be randomized to an optimal first line treatment in order to compare FAMS vs. PEER. PWD participants assigned to Step 1 treatment "FAMS" will have the option to co-enroll a friend/family member as a support person (SP) to receive text message support tailored to the goal set by the linked PWD. PWD participants assigned to Step 1 treatment "PEER" will be paired with another participant to provide each other peer support. |
|
| Experimental: Step 2: Optimal Second Line Treatment | Experimental | All PWD participants will be randomized at month 3 to FAMS or PEER. PWD participants assigned to Step 2 treatment "FAMS" will have the option to co-enroll a friend/family member as a support person (SP) to receive text message support tailored to the goal set by the linked PWD if not previously enrolled. PWD participants assigned to Step 2 treatment "PEER" will be paired with another participant to provide each other peer support. If they had previously enrolled a SP, the SP participant will stop receiving text messages. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAMS | Behavioral | PWD participants will receive FAMS components (monthly phone coaching and text message support for goals and medication adherence) for 3 months. PWD participants will receive high-quality print materials upon enrollment. Co-enrolled SP participants will receive high-quality print materials upon enrollment and receive text message support tailored to the goal set by the linked PWD. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | Net Promoter Score with scores ranging 0 to 100 where higher scores (scaled score >0) indicate good acceptability | 6 months post-baseline |
| Feasibility (Recruitment) | Number of participants screened/week | baseline |
| Feasibility (Recruitment) | Proportion of eligible screens who enroll | baseline |
| Feasibility (Treatment Adherence) | Proportion of sessions attended | 6 months post-baseline |
| Feasibility (Treatment Adherence) | Proportion of interactive texts with response | 6 months post-baseline |
| Feasibility (Assessment Completion) | Proportion of self-report measures completed | 3 and 6 months post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c | Hemoglobin A1c assessed by mail-in A1c kits from BioQuintex and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic management | Baseline and 3 and 6 months post-baseline |
| Change in Diabetes Distress |
Not provided
Inclusion Criteria:
PERSONS WITH DIABETES:
SUPPORT PERSONS:
Exclusion Criteria:
PERSONS WITH DIABETES
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37203 | United States |
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.
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Sequential Multiple Assignment Randomized Trial (SMART)
Not provided
Not provided
Not provided
|
| PEER | Behavioral | PWD participants will receive PEER components (monthly phone coaching and text message support for goals and medication adherence) for 3 months. PWD participants will receive high-quality print materials upon enrollment PWD participants assigned to PEER will be matched with another PWD participant assigned to peer to provide peer support to each other. |
|
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 3 and 6 months post-baseline |
| Change in Psychosocial Well-being | 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 3 and 6 months post-baseline |
| Change in Social Support for Diabetes | Assessed by the Diabetes Support Scale (DSS) with scores ranging 12 to 84 where higher scores indicate more social support for diabetes (better) | Baseline and 3 and 6 months post-baseline |
| D004700 | Endocrine System Diseases |