Back to resultsImproving Medication Adherence Among Underserved Patients With Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
REACH
Helpline and A1c results
REACH + FAMS
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 2
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
Sites / Locations
- Federally Qualified Health Centers and Vanderbilt Primary Care Clinics
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
REACH
REACH + FAMS
Helpline and A1c results
Arm Description
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.
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 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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT02409329
First Posted
March 9, 2015
Last Updated
August 6, 2020
Sponsor
Vanderbilt University Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT02409329
Brief Title
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
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 23, 2016 (Actual)
Primary Completion Date
June 4, 2019 (Actual)
Study Completion Date
June 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
512 (Actual)
8. Arms, Groups, and Interventions
Arm Title
REACH
Arm Type
Experimental
Arm Description
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.
Arm Title
REACH + FAMS
Arm Type
Experimental
Arm Description
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.
Arm Title
Helpline and A1c results
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
REACH
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Helpline and A1c results
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
REACH + FAMS
Other Intervention Name(s)
NCT02481596
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c)
Description
as measured by Hemoglobin A1c (%) with higher values indicating worse glycemic control and an improvement of 0.5% considered clinically meaningful
Time Frame
Baseline, 3 months, 6 months, 12 months, 15 months
Secondary Outcome Measure Information:
Title
Change in Self-reported Medication Adherence
Description
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
Time Frame
Baseline, 3 months, 6 months, 12 months, 15 months
Title
Change in Self-reported Medication Adherence
Description
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
Time Frame
Baseline, 3 months, 6 months, 12 months, 15 months
Other Pre-specified Outcome Measures:
Title
Change in Adherence to Dietary Behavior
Description
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)
Time Frame
Baseline, 3 months, 6 months, 12 months, 15 months
Title
Change in Adherence to Dietary Behavior
Description
Personal Diabetes Questionnaire diet subscale "Problem eating behavior"; possible range 1-6 with higher indicating more problem eating behavior (worse)
Time Frame
Baseline, 3 months, 6 months, 12 months, 15 months
Title
Change in Physical Activity
Description
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
Time Frame
Baseline, 3 months, 6 months, 12 months, 15 months
Title
Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control
Description
as measured by hemoglobin A1c (HbA1c, %) We may be under-powered to for these comparative analyses.
Time Frame
Baseline, 3 months, 6 months, 12 months, 15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsay S Mayberry, MS, PhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federally Qualified Health Centers and Vanderbilt Primary Care Clinics
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Beginning 6 months after final trial results publication. No end date.
IPD Sharing Access Criteria
Approval of a proposal by the study PI.
Citations:
PubMed Identifier
27609738
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.
Results Reference
background
PubMed Identifier
29636319
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.
Results Reference
background
PubMed Identifier
35948873
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.
Results Reference
derived
PubMed Identifier
31403688
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.
Results Reference
derived
Learn more about this trial
Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes
We'll reach out to this number within 24 hrs