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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
221
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.
University of Illinois Hospital and Health Sciences System
Chicago, Illinois, United States
Hemoglobin A1c
Time frame: 24 months
Self-reported medication adherence
A 3-item questionnaire will be administered to measure adherence to diabetes medications.
Time frame: 24 months
Blood Pressure
Time frame: 24 months
LDL Cholesterol
LDL Cholesterol will be measured as part of a Full Lipid profile blood test.
Time frame: 24 months
Diabetes Self-Management
Self-management will be measured by the revised 11-item Summary of Diabetes Self Care Activities questionnaire.
Time frame: 24 months
Health related quality of life
General health-related quality of life will be measured by the EuroQOL 5D (EQ-5D).
Time frame: 24 months
Diabetes related quality of life
Diabetes-related quality of life will be measured by the Diabetes Distress Screening Instrument (DDS4).
Time frame: 24 months
Depression
Measured with the nine-item Patient Health Questionnaire (PHQ-9)
Time frame: 24 months
Alcohol Misuse
Measured using the 3-item AUDIT-C questionnaire
Time frame: 24 months
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BMI
Height and weight will be taken at each time point to determine BMI
Time frame: 24 months
Social Support
4-item questionnaire measuring satisfaction with support from friends, family and health care team
Time frame: 24 months
Diabetes Self-efficacy
8 -item questionnaire measuring confidence in diabetes self-management skills
Time frame: 24 months