Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: REACH
* Behavioral: Helpline and A1c results
* Behavioral: REACH + FAMS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REACH<br>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. | Behavioral: REACH<br>* 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.<br>Behavioral: Helpline and A1c results<br>* 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.<br>|
| Experimental: REACH + FAMS<br>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. | Behavioral: Helpline and A1c results<br>* 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.<br>Behavioral: REACH + FAMS<br>* 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.<br>* Other names: NCT02481596;|
| Active Comparator: Helpline and A1c results<br>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. | Behavioral: Helpline and A1c results<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c) | as measured by Hemoglobin A1c (%) with higher values indicating worse glycemic control and an improvement of 0.5% considered clinically meaningful | Baseline, 3 months, 6 months, 12 months, 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Self-reported Medication Adherence | 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 | Baseline, 3 months, 6 months, 12 months, 15 months | 
| Change in Self-reported Medication Adherence | 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 | Baseline, 3 months, 6 months, 12 months, 15 months |