Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02409329
• Other study ID #: 140562
• Secondary ID: 1R01DK100694-01A
• Status: Completed
• Phase: N/A
• Start date: May 23, 2016
• Est. completion date: June 4, 2019

Study information

• Verified date: August 2020
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 512
• Est. completion date: June 4, 2019
• Est. primary completion date: June 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Federally Qualified Health Centers and Vanderbilt Primary Care Clinics	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Adherence to Dietary Behavior	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)	Baseline, 3 months, 6 months, 12 months, 15 months
Other	Change in Adherence to Dietary Behavior	Personal Diabetes Questionnaire diet subscale "Problem eating behavior"; possible range 1-6 with higher indicating more problem eating behavior (worse)	Baseline, 3 months, 6 months, 12 months, 15 months
Other	Change in Physical Activity	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	Baseline, 3 months, 6 months, 12 months, 15 months
Other	Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control	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
Primary	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	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
Secondary	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