JMIR Publications

ABSTRACT

Background:

Primary healthcare systems are uniquely positioned to provide access to strategies for reducing alcohol misuse and high-risk drinking, strategies which include mHealth apps. The extent of human interaction needed to achieve effective and cost-effective use of mHealth apps in primary care remains largely unexamined. This study seeks to understand how varying levels of human interaction affect the ways in which an mHealth intervention for the prevention and treatment of alcohol use disorders works or does not work, for whom, and under what circumstances.

Objective:

The primary aim is to detect the effectiveness of an mHealth intervention by assessing differences in self-reported risky drinking patterns and quality of life between participants in three study groups (self-monitored, peer-supported, and clinically integrated). Each group reflects differences in the level of human touch provided to support use of the intervention. The cost-effectiveness of each approach will be assessed .

Methods:

This Hybrid 1 study is an unblinded patient-level randomized clinical trial testing the effects of using an evidence-based mHealth system on participants’ drinking patterns and quality of life. There are two groups of participants for this study: individuals receiving the intervention and health care professionals practicing in the broader primary care environment. The intervention is a smartphone app encouraging users to reduce their alcohol consumption within the context of integrative medicine using techniques to build healthy habits. Primary outcomes for quantitative analysis will be participant data on their risky drinking days and quality of life, as well as app usage from weekly and quarterly surveys. Cost measures include intervention and implementation costs. Cost per participant will be determined for each study arm with intervention and implementation costs separated within each group. There will also be a qualitative assessment of health care professionals’ engagement with the app as well as their thoughts on participant experience with the app.

Results:

This protocol was approved on November 18, 2019 by the Health Sciences Minimal Risk Institutional Review Board with subsequent annual reviews. Recruitment began on March 06, 2020 but was suspended on March 13, 2020 due to COVID-19 restrictions. Limited recruitment resumed on July 6, 2020. Trial status as of June 9, 2021: 257 participants are enrolled in the study toward a planned enrollment of 546 participants.

Conclusions:

New knowledge gained from this study could have wide and lasting benefits related to the integration of mHealth systems for alcohol use disorders in primary healthcare systems. Results of the study will guide policy makers and providers to cost-effective ways to incorporate technology in health care. Clinical Trial: ClinicalTrials.gov Identifier: NCT04011644