mHealth for Diabetes Adherence Support
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Behavioral: mHealth for Diabetes Adherence Support
- Registration Number
- NCT02990299
- Lead Sponsor
- University of Illinois at Chicago
- 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.
- Detailed Description
Many African-Americans and Latinos with diabetes do not achieve recommended diabetes goals placing them at high risk for complications. Team-based models of care can help in reaching goals of therapy. Additionally, mobile health (mHealth) technologies can further improve outcomes among those more difficult to reach. This study will evaluate the impact of a team-based, mHealth intervention designed to improve medication adherence, healthy eating, and physical activity behaviors. The investigators will compare this mHealth approach with usual care.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 221
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mHealth for Diabetes Adherence Support 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.
- Primary Outcome Measures
Name Time Method Hemoglobin A1c 24 months
- Secondary Outcome Measures
Name Time Method Blood Pressure 24 months LDL Cholesterol 24 months LDL Cholesterol will be measured as part of a Full Lipid profile blood test.
Diabetes Self-Management 24 months Self-management will be measured by the revised 11-item Summary of Diabetes Self Care Activities questionnaire.
Self-reported medication adherence 24 months A 3-item questionnaire will be administered to measure adherence to diabetes medications.
Health related quality of life 24 months General health-related quality of life will be measured by the EuroQOL 5D (EQ-5D).
Depression 24 months Measured with the nine-item Patient Health Questionnaire (PHQ-9)
Diabetes Self-efficacy 24 months 8 -item questionnaire measuring confidence in diabetes self-management skills
Diabetes related quality of life 24 months Diabetes-related quality of life will be measured by the Diabetes Distress Screening Instrument (DDS4).
Social Support 24 months 4-item questionnaire measuring satisfaction with support from friends, family and health care team
Alcohol Misuse 24 months Measured using the 3-item AUDIT-C questionnaire
BMI 24 months Height and weight will be taken at each time point to determine BMI
Trial Locations
- Locations (1)
University of Illinois Hospital and Health Sciences System
🇺🇸Chicago, Illinois, United States