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Completed

NCT Number: NCT02409329

Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federally Qualified Health Centers and Vanderbilt Primary Care Clinics

Nashville, Tennessee, 37203, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

REACH

Behavioral

The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors.

Helpline and A1c results

Behavioral

Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.

REACH + FAMS

Behavioral

The intervention consists of REACH individually-focused text messaging, plus family-focused phone coaching session, goal-focused text messaging, and the option to invite a family member/support person to receive text messaging.

Other names: NCT02481596

Primary outcomes

  1. 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

  1. Change in Self-reported Medication Adherence

    Time frame: Baseline, 3 months, 6 months, 12 months, 15 months

    as measured by the Summary of Diabetes Self-Care Activities (SDSCA) Medications subscale; response options are days in the last week ranging from 0 to 7, with 7 representing perfect adherence

  2. Change in Self-reported Medication Adherence

    Time frame: 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

Other outcomes

  1. Change in Adherence to Dietary Behavior

    Time frame: Baseline, 3 months, 6 months, 12 months, 15 months

    as measured by the Personal Diabetes Questionnaire diet subscale "Use of information for decision making"; possible range 1-6, higher indicates more use of dietary information (better)

  2. Change in Adherence to Dietary Behavior

    Time frame: Baseline, 3 months, 6 months, 12 months, 15 months

    Personal Diabetes Questionnaire diet subscale "Problem eating behavior"; possible range 1-6 with higher indicating more problem eating behavior (worse)

  3. Change in Physical Activity

    Time frame: Baseline, 3 months, 6 months, 12 months, 15 months

    as measured by International Physical Activity Questionnaire-Short form [metabolic equivalent minutes (MET-minutes) per week] where more MET-minutes per week indicates more physical activity

  4. Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control

    Time frame: Baseline, 3 months, 6 months, 12 months, 15 months

    as measured by hemoglobin A1c (HbA1c, %) We may be under-powered to for these comparative analyses.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 6, 2015
Registry last updated
Aug 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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