Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes

Vanderbilt University Medical Center

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: REACH + FAMS; Behavioral: REACH; Behavioral: Helpline and A1c results

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02409329

140562

1R01DK100694-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 512 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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512 participants in 3 patient groups

REACH

Experimental group

Description:

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.

Treatment:

Behavioral: Helpline and A1c results

Behavioral: REACH

REACH + FAMS

Experimental group

Description:

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.

Treatment:

Behavioral: Helpline and A1c results

Behavioral: REACH + FAMS

Helpline and A1c results

Active Comparator group

Description:

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.

Treatment:

Behavioral: Helpline and A1c results