Type 2 Diabetes
Conditions
Keywords
type 2 diabetes, SMART
Brief summary
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.
Interventions
BEHAVIORALFAMS
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.
BEHAVIORALPEER
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.
Sponsors
Vanderbilt University Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Sequential Multiple Assignment Randomized Trial (SMART)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
PERSONS WITH DIABETES: * Speaks and reads in English * 18-75 years old * Diagnosed with type 2 diabetes * Receiving outpatient care from a partnering clinic * Community-dwelling (e.g., not in a nursing facility) * Prescribed at least one daily diabetes medication * Owns a mobile phone * Elevated diabetes distress or low diabetes self-efficacy * Willing to invite a close friend or family member to co-participate SUPPORT PERSONS: * Speaks and reads in English * 18 years or older * Owns a mobile phone
Exclusion criteria
PERSONS WITH DIABETES * Unable to communicate by phone * Currently pregnant * Currently undergoing treatment for cancer (e.g., radiation, chemotherapy) * Diagnosed with end-stage renal disease * Receiving hospice services * Diagnosed with congestive heart failure * Diagnosed with dementia * Diagnosed with schizophrenia * Demonstrated an inability to receive and respond to a text * Does not take medication on his/her own/medication administered by someone else SUPPORT PERSONS * Demonstrated inability to receive \& respond to a text * Unable to communicate by phone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | 6 months post-baseline | Net Promoter Score with scores ranging 0 to 100 where higher scores (scaled score \>0) indicate good acceptability |
| Feasibility (Recruitment) | baseline | Number of participants screened/week |
| Feasibility (Treatment Adherence) | 6 months post-baseline | Proportion of sessions attended |
| Feasibility (Assessment Completion) | 3 and 6 months post-baseline | Proportion of self-report measures completed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1c | Baseline and 3 and 6 months post-baseline | 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 |
| Change in Diabetes Distress | Baseline and 3 and 6 months post-baseline | 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) |
| Change in Psychosocial Well-being | Baseline and 3 and 6 months post-baseline | 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) |
| Change in Social Support for Diabetes | Baseline and 3 and 6 months post-baseline | Assessed by the Diabetes Support Scale (DSS) with scores ranging 12 to 84 where higher scores indicate more social support for diabetes (better) |
Countries
United States
Outcome results
None listed