Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 23, 2019
Date Accepted: Jan 21, 2021
A Pharmacist and Health Coach mHealth Intervention for Type 2 Diabetes: Protocol for a Randomized Controlled Cross-Over Study
ABSTRACT
Background:
Aggressive management of blood glucose, blood pressure, and cholesterol through medication and lifestyle adherence are necessary to minimize the adverse health outcomes from type 2 diabetes. However, numerous psychosocial and environmental barriers to adherence exist that prevent low income, urban, ethnic minority populations from achieving their management goals and result in diabetic complications. Health coaches working with clinical pharmacists represents a promising strategy to address common diabetes management barriers. mHealth tools may further enhance their ability to support vulnerable minority populations in diabetes management.
Objective:
The aim of this study is to evaluate a clinical pharmacist/health coach mHealth intervention for type 2 diabetes management in urban African Americans and Latinos.
Methods:
A two-year, cross-over randomized controlled study will evaluate the effectiveness of a health coach and clinical pharmacist team utilizing mHealth tools in providing lifestyle and medication support compared to usual care. Patients are randomized to receive an mHealth team-based intervention during year 1 or year 2. We will recruit 220 urban African-American or Latino adults with uncontrolled type 2 diabetes (hemoglobin A1c [HbA1c] ≥ 8%) through UI Health. The intervention includes: (1) health coaches supporting patients through home visits, phone calls, and text messaging; and (2) clinical pharmacists supporting patients through videoconferences facilitated by health coaches. Data collection includes physiologic (HbA1c, blood pressure, weight, and lipid profile) and survey measures (medication adherence, diabetes-related behaviors, and quality of life). Data collection during the second year of study will determine maintenance of any physiologic improvement among participants receiving the intervention during the first year.
Results:
Participant enrollment began in March, 2017. We have recruited 212 patients. Intervention delivery and data collection will continue through November, 2021. Results are expected to be published by May, 2022.
Conclusions:
This is among the first randomized, controlled trials to incorporate health coaches, clinical pharmacists, and mHealth technologies to increase access to diabetes support among a vulnerable population of urban African-Americans and Latinos. Clinical Trial: ClinicalTrials.gov with identifier NCT02990299.
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.