Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT02409329
- Lead Sponsor
- Vanderbilt University Medical Center
- Brief Summary
This study evaluates a mobile phone-delivered intervention, called REACH (Rapid Education/Encouragement And Communications for Health), in supporting adults with type 2 diabetes in their self-management relative to a control group. The goal of this study is to determine if individually tailored content (based on the Information-Motivation-Behavioral Skills Model) delivered to the participant via text messages can improve the participant's glycemic control and adherence to diabetes medications. We will test whether our intervention improves adherence-related information, motivation, and behavioral skills and whether improving these mechanisms drives improvements in adherence and, in turn, glycemic control.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 512
- Adults aged 18 years and older
- Individuals who have received a diagnosis for type 2 diabetes mellitus
- Enrolled as a patient at a participating community health center
- Individuals currently being treated with oral and/or injectable diabetes medications
- Non-English speakers
- Individuals who report they do not have a cell phone
- Individuals unwilling and/or not able to provide written informed consent
- Individuals with unintelligible speech (e.g., dysarthria)
- Individuals with a severe hearing or visual impairment
- Individuals who report a caregiver administers their diabetes medications Individuals who fail the cognitive screener administered during the baseline survey
- Individuals who cannot receive, read, and respond to a text after instruction from a trained research assistant
- Individuals whose most recent (within 12 months) HbA1c value was 6.8% or greater
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c) Baseline, 3 months, 6 months, 12 months, 15 months as measured by Hemoglobin A1c (%) with higher values indicating worse glycemic control and an improvement of 0.5% considered clinically meaningful
- Secondary Outcome Measures
Name Time Method Change in Self-reported Medication Adherence Baseline, 3 months, 6 months, 12 months, 15 months as measured by the Adherence to Refills and Medications Scale for Diabetes (ARMS-D); reverse coded such that higher scores indicate better adherence on a scale from 11 to 44
Trial Locations
- Locations (1)
Federally Qualified Health Centers and Vanderbilt Primary Care Clinics
🇺🇸Nashville, Tennessee, United States
Federally Qualified Health Centers and Vanderbilt Primary Care Clinics🇺🇸Nashville, Tennessee, United States