mHealth for Diabetes Adherence Support

Diabetes Mellitus, Type 2 Clinical Trial

— mDAS  

Official title:

mHealth for Diabetes Adherence Support

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02990299
• Other study ID #: 2016-0380
• Secondary ID: 1R01DK108141
• Status: Completed
• Phase: N/A
• Start date: March 24, 2017
• Est. completion date: January 7, 2022

Study information

• Verified date: June 2023
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: January 7, 2022
• Est. primary completion date: January 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
United States	University of Illinois Hospital and Health Sciences System	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Healthcare utilization	This will include costs associated with hospital admissions, emergency room and outpatient visits and prescription medications.	24 months
Other	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
Other	Health Coach Satisfaction	A survey administered to the patient for feedback on their assigned health coach.	1 year after health coach assignment
Primary	Hemoglobin A1c		24 months
Secondary	Self-reported medication adherence	A 3-item questionnaire will be administered to measure adherence to diabetes medications.	24 months
Secondary	Blood Pressure		24 months
Secondary	LDL Cholesterol	LDL Cholesterol will be measured as part of a Full Lipid profile blood test.	24 months
Secondary	Diabetes Self-Management	Self-management will be measured by the revised 11-item Summary of Diabetes Self Care Activities questionnaire.	24 months
Secondary	Health related quality of life	General health-related quality of life will be measured by the EuroQOL 5D (EQ-5D).	24 months
Secondary	Diabetes related quality of life	Diabetes-related quality of life will be measured by the Diabetes Distress Screening Instrument (DDS4).	24 months
Secondary	Depression	Measured with the nine-item Patient Health Questionnaire (PHQ-9)	24 months
Secondary	Alcohol Misuse	Measured using the 3-item AUDIT-C questionnaire	24 months
Secondary	BMI	Height and weight will be taken at each time point to determine BMI	24 months
Secondary	Social Support	4-item questionnaire measuring satisfaction with support from friends, family and health care team	24 months
Secondary	Diabetes Self-efficacy	8 -item questionnaire measuring confidence in diabetes self-management skills	24 months