Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes
NCT ID: NCT02409329
Last Updated: 2020-08-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
512 participants
INTERVENTIONAL
2016-05-23
2019-06-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
REACH
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.
Helpline and A1c results
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.
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.
Helpline and A1c results
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.
REACH + FAMS
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.
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.
Helpline and A1c results
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.
Interventions
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REACH
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.
Helpline and A1c results
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.
REACH + FAMS
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Vanderbilt University Medical Center
OTHER
Responsible Party
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Lindsay Mayberry
Assistant Professor of Medicine
Principal Investigators
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Lindsay S Mayberry, MS, PhD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Federally Qualified Health Centers and Vanderbilt Primary Care Clinics
Nashville, Tennessee, United States
Countries
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References
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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.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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140562
Identifier Type: -
Identifier Source: org_study_id
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