Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes
2 other identifiers
interventional
512
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started May 2016
Longer than P75 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2015
CompletedFirst Posted
Study publicly available on registry
April 6, 2015
CompletedStudy Start
First participant enrolled
May 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2019
CompletedResults Posted
Study results publicly available
August 17, 2020
CompletedAugust 17, 2020
August 1, 2020
3 years
March 9, 2015
April 1, 2020
August 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Change in Self-reported Medication Adherence
Baseline, 3 months, 6 months, 12 months, 15 months
Change in Self-reported Medication Adherence
Baseline, 3 months, 6 months, 12 months, 15 months
Other Outcomes (4)
Change in Adherence to Dietary Behavior
Baseline, 3 months, 6 months, 12 months, 15 months
Change in Adherence to Dietary Behavior
Baseline, 3 months, 6 months, 12 months, 15 months
Change in Physical Activity
Baseline, 3 months, 6 months, 12 months, 15 months
- +1 more other outcomes
Study Arms (3)
REACH
EXPERIMENTALParticipants 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
EXPERIMENTALIn 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.
Helpline and A1c results
ACTIVE COMPARATORParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federally Qualified Health Centers and Vanderbilt Primary Care Clinics
Nashville, Tennessee, 37203, United States
Related Publications (4)
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.
PMID: 27609738BACKGROUNDNelson 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.
PMID: 29636319BACKGROUNDRoddy 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.
PMID: 35948873DERIVEDMayberry 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.
PMID: 31403688DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lindsay S. Mayberry, PhD, MS
- Organization
- Vanderbilt University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Lindsay S Mayberry, MS, PhD
Vanderbilt University Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
March 9, 2015
First Posted
April 6, 2015
Study Start
May 23, 2016
Primary Completion
June 4, 2019
Study Completion
June 4, 2019
Last Updated
August 17, 2020
Results First Posted
August 17, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 6 months after final trial results publication. No end date.
- Access Criteria
- Approval of a proposal by the study PI.
Individual participant data collected during the trial will be de-identified and made available following publication of the 15-month trial results to researchers who provide a methodologically sound proposal.