- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02409329
Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tennessee
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Nashville, Tennessee, United States, 37203
- Federally Qualified Health Centers and Vanderbilt Primary Care Clinics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
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.
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.
|
Experimental: 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. |
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.
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:
|
Active Comparator: 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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline, 3 months, 6 months, 12 months, 15 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Baseline, 3 months, 6 months, 12 months, 15 months
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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
|
Baseline, 3 months, 6 months, 12 months, 15 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Baseline, 3 months, 6 months, 12 months, 15 months
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Change in Adherence to Dietary Behavior
Time Frame: Baseline, 3 months, 6 months, 12 months, 15 months
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Personal Diabetes Questionnaire diet subscale "Problem eating behavior"; possible range 1-6 with higher indicating more problem eating behavior (worse)
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Baseline, 3 months, 6 months, 12 months, 15 months
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Change in Physical Activity
Time Frame: Baseline, 3 months, 6 months, 12 months, 15 months
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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
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Baseline, 3 months, 6 months, 12 months, 15 months
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Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control
Time Frame: Baseline, 3 months, 6 months, 12 months, 15 months
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as measured by hemoglobin A1c (HbA1c, %) We may be under-powered to for these comparative analyses.
|
Baseline, 3 months, 6 months, 12 months, 15 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lindsay S Mayberry, MS, PhD, Vanderbilt University Medical Center
Publications and helpful links
General Publications
- Nelson LA, Mayberry LS, Wallston K, Kripalani S, Bergner EM, Osborn CY. Development and Usability of REACH: A Tailored Theory-Based Text Messaging Intervention for Disadvantaged Adults With Type 2 Diabetes. JMIR Hum Factors. 2016 Sep 8;3(2):e23. doi: 10.2196/humanfactors.6029.
- Nelson LA, Wallston KA, Kripalani S, Greevy RA Jr, Elasy TA, Bergner EM, Gentry CK, Mayberry LS. Mobile Phone Support for Diabetes Self-Care Among Diverse Adults: Protocol for a Three-Arm Randomized Controlled Trial. JMIR Res Protoc. 2018 Apr 10;7(4):e92. doi: 10.2196/resprot.9443.
- Roddy MK, Mayberry LS, Nair D, Cavanaugh KL. Exploring mHealth potential to improve kidney function: secondary analysis of a randomized trial of diabetes self-care in diverse adults. BMC Nephrol. 2022 Aug 10;23(1):280. doi: 10.1186/s12882-022-02885-6.
- Mayberry LS, Bergner EM, Harper KJ, Laing S, Berg CA. Text messaging to engage friends/family in diabetes self-management support: acceptability and potential to address disparities. J Am Med Inform Assoc. 2019 Oct 1;26(10):1099-1108. doi: 10.1093/jamia/ocz091.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 140562
- 1R01DK100694-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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