mHealth for Diabetes Adherence Support
mDAS
2 other identifiers
interventional
221
1 country
1
Brief Summary
The purpose of this research study is to determine the benefit and cost of including health coaches, clinical pharmacists and mobile health (mHealth) tools such as text messaging and videoconferencing in diabetes management support services for African-Americans and Latinos with uncontrolled Type 2 Diabetes.
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 Mar 2017
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
December 5, 2016
CompletedFirst Posted
Study publicly available on registry
December 13, 2016
CompletedStudy Start
First participant enrolled
March 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 7, 2022
CompletedJune 13, 2023
June 1, 2023
4.8 years
December 5, 2016
June 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin A1c
24 months
Secondary Outcomes (11)
Self-reported medication adherence
24 months
Blood Pressure
24 months
LDL Cholesterol
24 months
Diabetes Self-Management
24 months
Health related quality of life
24 months
- +6 more secondary outcomes
Other Outcomes (3)
Healthcare utilization
24 months
Program cost
24 months
Health Coach Satisfaction
1 year after health coach assignment
Study Arms (2)
Usual Care
NO INTERVENTIONParticipants will receive their usual care for the first year of their enrollment in the study. They will receive a referral to a diabetes educator and a clinical pharmacist, a one-page sheet of contact information for their healthcare providers, and paper-based, low-literacy diabetes information. After one year, they will change to the mDAS intervention arm for one year.
mHealth for Diabetes Adherence Support
EXPERIMENTALParticipants will receive in-person support from a health coach and a clinical pharmacist with whom they will meet with regularly via videoconference. After one year, participants who have completed the mDAS intervention will be monitored for an additional year with usual care to evaluate maintenance.
Interventions
Participants will be paired with a health coach who will provide ongoing support and resources in medication and lifestyle adherence and diabetes self-management. The health coach will perform regular home visits, telephone support and tailored text-messages based on the participant's preferences and needs. They will help assess barriers to adherence and use motivational interviewing to help patients set goals and create action plans. They will also facilitate videoconferences with an assigned clinical pharmacist who will provide consultation on medication use, reconciliation and adherence, identify therapeutic goals and formulate an approved plan of care.
Eligibility Criteria
You may qualify if:
- Self-identified as Latino/Hispanic or African-American
- Verbal fluency in English or Spanish
- Latest A1c ≥ 8.0% (within 3 mo)
- History of Type 2 Diabetes (\> 1 year)
- Between the ages of 21 and 75 years
- Unlimited mobile phone/text messaging plan with ability to reply to text messages
- Home environment capable of video conferencing with wireless signal
- Receives primary care at UI Health clinical site for at least one year, with one visit during past year
- Able and willing to provide informed consent (agree to data collection requirements, accept randomization, agree to home visitation with HC and pharmacist involvement, and participate for two years)
You may not qualify if:
- Unable to verbalize comprehension of study or impaired decision making
- Family/household member already participating in same study
- Currently receiving regular pharmacist support through Medication Therapy Management or equivalent
- History of, or planned, gastric bypass or transplant surgery
- History of bipolar or psychotic disorder
- Other severe comorbidities that require complex, aggressive, or palliative treatment, e.g., stage 4 or greater renal disease, liver failure, cancer (other than nonmelanoma skin cancer), terminal illness
- Investigator discretion for safety concerns
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Illinois Hospital and Health Sciences System
Chicago, Illinois, 60612, United States
Related Publications (2)
Sharp LK, Biggers A, Perez R, Henkins J, Tilton J, Gerber BS. A Pharmacist and Health Coach-Delivered Mobile Health Intervention for Type 2 Diabetes: Protocol for a Randomized Controlled Crossover Study. JMIR Res Protoc. 2021 Mar 10;10(3):e17170. doi: 10.2196/17170.
PMID: 33688847RESULTGerber BS, Biggers A, Tilton JJ, Smith Marsh DE, Lane R, Mihailescu D, Lee J, Sharp LK. Mobile Health Intervention in Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2333629. doi: 10.1001/jamanetworkopen.2023.33629.
PMID: 37773498DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ben S Gerber, MD, MPH
University of Illinois at Chicago
- PRINCIPAL INVESTIGATOR
Lisa K Sharp, PhD
University of Illinois at Chicago
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
December 5, 2016
First Posted
December 13, 2016
Study Start
March 24, 2017
Primary Completion
January 7, 2022
Study Completion
January 7, 2022
Last Updated
June 13, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share