Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes

Not Applicable

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Behavioral: REACH
Behavioral: Helpline and A1c results
Behavioral: REACH + FAMS

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

Arm && Interventions

Group	Intervention	Description
REACH	Helpline and A1c results	Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
REACH + FAMS	Helpline and A1c results	In addition to the REACH text messages tailored to user's individual barriers to adherence, participants will receive FAMS components (monthly phone coaching and text messages supporting a goal set in coaching, plus the option to invite a family member/support person to receive text messages) for six months. After six months, participants in this arm will receive REACH text messages only. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
REACH + FAMS	REACH + FAMS	In addition to the REACH text messages tailored to user's individual barriers to adherence, participants will receive FAMS components (monthly phone coaching and text messages supporting a goal set in coaching, plus the option to invite a family member/support person to receive text messages) for six months. After six months, participants in this arm will receive REACH text messages only. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
REACH	REACH	Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
Helpline and A1c results	Helpline and A1c results	Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring). All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.

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