Clinical trial NCT02409329: Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes
Official title: Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2015-04-06
Enrollment: 512
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c)
timeFrame: Baseline, 3 months, 6 months, 12 months, 15 months
Secondary outcomes:
measure: Change in Self-reported Medication Adherence
timeFrame: Baseline, 3 months, 6 months, 12 months, 15 months
measure: Change in Self-reported Medication Adherence
timeFrame: Baseline, 3 months, 6 months, 12 months, 15 months
Other outcomes:
measure: Change in Adherence to Dietary Behavior
timeFrame: Baseline, 3 months, 6 months, 12 months, 15 months
measure: Change in Adherence to Dietary Behavior
timeFrame: Baseline, 3 months, 6 months, 12 months, 15 months
measure: Change in Physical Activity
timeFrame: Baseline, 3 months, 6 months, 12 months, 15 months
measure: Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control
timeFrame: Baseline, 3 months, 6 months, 12 months, 15 months
Locations:
city: Nashville
country: United States
facility: Federally Qualified Health Centers and Vanderbilt Primary Care Clinics
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Lindsay S Mayberry, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.