Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
221 participants
INTERVENTIONAL
2017-03-24
2022-01-07
Brief Summary
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Detailed Description
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Clinical pharmacists and health coaches (HC) will deliver our proposed team-based intervention. mHealth delivery includes mobile phone text messaging, secure videoconferencing, and HC home visits. Pharmacists will focus on medication reconciliation and adherence. Health coaches will help identify psychosocial and environmental challenges to adherence in a culturally-sensitive manner. Together, they can assist in goal-setting, problem-solving, negotiation of competing priorities, and provide social support leveraging mHealth technologies.
Preliminary data from previous research by the research team supports the role of health coaches partnering with clinic- based pharmacists in improving diabetes outcomes in minorities. In the proposed mHealth intervention, patient- pharmacist videoconferencing will eliminate the need for in-person visits with a pharmacist, which is impractical for many low-income patients. In addition, pilot work suggests that text messaging is a preferable means of communication and may facilitate more frequent contact with patients.
This is a randomized, controlled trial to evaluate the effectiveness of an mHealth diabetes adherence support intervention delivered by clinical pharmacists and health coaches. The research team will randomize 220 patients through UI Health to either: (1) mHealth diabetes adherence support through clinical pharmacists and health coaches; or (2) usual care. After one year, patients completing the mHealth intervention will be monitored for an additional year while the usual care group receives the mHealth approach. Outcomes include medication adherence, hemoglobin A1c, blood pressure, and LDL-cholesterol levels. The specific aims include: (1) evaluate the effectiveness of an mHealth diabetes adherence support intervention delivered by clinical pharmacists and health coaches to African-American and Latino adults with uncontrolled type 2 diabetes; (2) evaluate the maintenance of improved diabetes behaviors as well as clinical outcomes one year after completing the intervention; (3) evaluate the cost and cost-effectiveness of mHealth diabetes adherence support compared to usual care; and (4) evaluate the reach, adoption, and implementation of mHealth diabetes adherence support based on the RE-AIM framework.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Usual Care
Participants 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.
No interventions assigned to this group
mHealth for Diabetes Adherence Support
Participants 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.
mHealth for Diabetes Adherence Support
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.
Interventions
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mHealth for Diabetes Adherence Support
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
21 Years
75 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Illinois at Chicago
OTHER
Responsible Party
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Ben Gerber
Professor of Medicine
Principal Investigators
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Ben S Gerber, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago
Lisa K Sharp, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago
Locations
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University of Illinois Hospital and Health Sciences System
Chicago, Illinois, United States
Countries
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References
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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.
Gerber 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.
Other Identifiers
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2016-0380
Identifier Type: -
Identifier Source: org_study_id
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