Clinical trial NCT02990299: mHealth for Diabetes Adherence Support
Official title: mHealth for Diabetes Adherence Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Medication Adherence
Telemedicine
Community Health Workers
Pharmacists
Mobile Health
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-12-13
Enrollment: 221
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A 2-arm, parallel, randomized controlled trial. Patients are randomized 1:1 to (1) mHealth diabetes adherence support intervention for one year and monitored with usual care for the second year, or (2) wait-list usual care for one year, then intervention during the second year.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 24 months
Secondary outcomes:
measure: Self-reported medication adherence
timeFrame: 24 months
measure: Blood Pressure
timeFrame: 24 months
measure: LDL Cholesterol
timeFrame: 24 months
measure: Diabetes Self-Management
timeFrame: 24 months
measure: Health related quality of life
timeFrame: 24 months
measure: Diabetes related quality of life
timeFrame: 24 months
measure: Depression
timeFrame: 24 months
measure: Alcohol Misuse
timeFrame: 24 months
measure: BMI
timeFrame: 24 months
measure: Social Support
timeFrame: 24 months
measure: Diabetes Self-efficacy
timeFrame: 24 months
Other outcomes:
measure: Healthcare utilization
timeFrame: 24 months
measure: Program cost
timeFrame: 24 months
measure: Health Coach Satisfaction
timeFrame: 1 year after health coach assignment
Locations:
city: Chicago
country: United States
facility: University of Illinois Hospital and Health Sciences System
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Ben S Gerber, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois at Chicago
name: Lisa K Sharp, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.