MObile Support Adapted to Individual Contexts
Enrolling by invitation · Not applicable
Conditions studied: Type 2 Diabetes
In brief
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: 1. Does the diabetes education and support delivered via the MOSAIC adaptive mobile phone-delivered intervention improve outcomes more than diabetes education and support delivered via print materials alone? This aim compares the study arms on outcomes such as glycemic management (hemoglobin A1c), diabetes distress, and psychosocial well-being. This aim also compares the study arms on intervention targets (mediators) including diabetes self-efficacy and self-care behaviors. 2. For whom does the MOSAIC adaptive tailoring approach improve outcomes more than the print materials alone? This aim examines how well the tailoring rules used for the MOSAIC intervention worked for different participants on the outcomes examined in the first aim. 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.
Key facts
- Study ID
- NCT06828549
- Run by
- Vanderbilt University Medical Center
- People needed
- 547
- Starts
- 2025-03-21
- Expected to finish
- 2028-11-30
- Last updated by the study team
- 2026-03-05
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 diabetes medication
- Owns a mobile phone
- SUPPORT PERSONS:
- Speaks and reads in English
- 18 years or older
- Owns a mobile phone
You may not qualify if…
- 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
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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