Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Vanderbilt University Medical Center
- Enrollment
- 512
- Locations
- 1
- Primary Endpoint
- Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Lindsay Mayberry
Assistant Professor of Medicine
Vanderbilt University Medical Center
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c)
Time Frame: 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 Outcomes
- Change in Self-reported Medication Adherence(Baseline, 3 months, 6 months, 12 months, 15 months)