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Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes

Not Applicable
Completed
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Change in Self-reported Medication AdherenceBaseline, 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

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