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mHealth for Diabetes Adherence Support (mDAS)

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ClinicalTrials.gov Identifier: NCT02990299
Recruitment Status : Enrolling by invitation
First Posted : December 13, 2016
Last Update Posted : October 26, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Ben Gerber, 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: mHealth for Diabetes Adherence Support Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: mHealth for Diabetes Adherence Support
Actual Study Start Date : March 24, 2017
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
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 crossover to the mDAS intervention arm for one year.
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 Name: mDAS




Primary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Self-reported medication adherence [ Time Frame: 24 months ]
    A 3-item questionnaire will be administered to measure adherence to diabetes medications.

  2. Blood Pressure [ Time Frame: 24 months ]
  3. LDL Cholesterol [ Time Frame: 24 months ]
    LDL Cholesterol will be measured as part of a Full Lipid profile blood test.

  4. Diabetes Self-Management [ Time Frame: 24 months ]
    Self-management will be measured by the revised 11-item Summary of Diabetes Self Care Activities questionnaire.

  5. Health related quality of life [ Time Frame: 24 months ]
    General health-related quality of life will be measured by the EuroQOL 5D (EQ-5D).

  6. Diabetes related quality of life [ Time Frame: 24 months ]
    Diabetes-related quality of life will be measured by the Diabetes Distress Screening Instrument (DDS4).

  7. Depression [ Time Frame: 24 months ]
    Measured with the nine-item Patient Health Questionnaire (PHQ-9)

  8. Alcohol Misuse [ Time Frame: 24 months ]
    Measured using the 3-item AUDIT-C questionnaire

  9. BMI [ Time Frame: 24 months ]
    Height and weight will be taken at each time point to determine BMI

  10. Social Support [ Time Frame: 24 months ]
    4-item questionnaire measuring satisfaction with support from friends, family and health care team

  11. Diabetes Self-efficacy [ Time Frame: 24 months ]
    8 -item questionnaire measuring confidence in diabetes self-management skills


Other Outcome Measures:
  1. Healthcare utilization [ Time Frame: 24 months ]
    This will include costs associated with hospital admissions, emergency room and outpatient visits and prescription medications.

  2. Program cost [ Time Frame: 24 months ]
    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.

  3. Health Coach Satisfaction [ Time Frame: 1 year after health coach assignment ]
    A survey administered to the patient for feedback on their assigned health coach.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990299


Locations
United States, Illinois
University of Illinois Hospital and Health Sciences System
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
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

Responsible Party: Ben Gerber, Professor of Medicine, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02990299     History of Changes
Other Study ID Numbers: 2016-0380
1R01DK108141 ( U.S. NIH Grant/Contract )
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ben Gerber, University of Illinois at Chicago:
Diabetes Mellitus, Type 2
Medication Adherence
Telemedicine
Community Health Workers
Pharmacists
Mobile Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases