mHealth for Diabetes Adherence Support (mDAS)

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: mHealth for Diabetes Adherence Support

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.

• Study Type: Interventional
• Enrollment (Actual): 221
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois Hospital and Health Sciences System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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 Names: mDAS
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hemoglobin A1c	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported medication adherence	A 3-item questionnaire will be administered to measure adherence to diabetes medications.	24 months
Blood Pressure		24 months
LDL Cholesterol	LDL Cholesterol will be measured as part of a Full Lipid profile blood test.	24 months
Diabetes Self-Management	Self-management will be measured by the revised 11-item Summary of Diabetes Self Care Activities questionnaire.	24 months
Health related quality of life	General health-related quality of life will be measured by the EuroQOL 5D (EQ-5D).	24 months
Diabetes related quality of life	Diabetes-related quality of life will be measured by the Diabetes Distress Screening Instrument (DDS4).	24 months
Depression	Measured with the nine-item Patient Health Questionnaire (PHQ-9)	24 months
Alcohol Misuse	Measured using the 3-item AUDIT-C questionnaire	24 months
BMI	Height and weight will be taken at each time point to determine BMI	24 months
Social Support	4-item questionnaire measuring satisfaction with support from friends, family and health care team	24 months
Diabetes Self-efficacy	8 -item questionnaire measuring confidence in diabetes self-management skills	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare utilization	This will include costs associated with hospital admissions, emergency room and outpatient visits and prescription medications.	24 months
Program cost	This will include costs associated with the intervention including pharmacists and health coaches (training, salaries, implementation), educational materials, tablet computers and associated data service, text messaging and videoconferencing.	24 months
Health Coach Satisfaction	A survey administered to the patient for feedback on their assigned health coach.	1 year after health coach assignment

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Ben S Gerber, MD, MPH, University of Illinois at Chicago; Principal Investigator: Lisa K Sharp, PhD, University of Illinois at Chicago

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2017
• Primary Completion (Actual): January 7, 2022
• Study Completion (Actual): January 7, 2022

Study Registration Dates

• First Submitted: December 5, 2016
• First Submitted That Met QC Criteria: December 8, 2016
• First Posted (Estimated): December 13, 2016

Study Record Updates

• Last Update Posted (Actual): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 9, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Telemedicine; Mobile Health; Diabetes Mellitus, Type 2; Medication Adherence; Community Health Workers; Pharmacists
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2016-0380; 1R01DK108141 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No