Abstract
BackgroundThe extent of human interaction needed to achieve effective and cost-effective use of mobile health (mHealth) apps for individuals with mild to moderate alcohol use disorder (AUD) 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 AUDs works or does not work, for whom, and under what circumstances.ObjectiveThe 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). The cost-effectiveness of each approach will also be assessed.MethodsThis hybrid type 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 health care environment. The intervention is a smartphone app that encourages users to reduce their alcohol consumption within the context of integrative medicine using techniques to build healthy habits. The primary outcomes for quantitative analysis will be participant data on their risky drinking days and quality of life as well as app use from weekly and quarterly surveys. Cost measures include intervention and implementation costs. The 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.ResultsThis protocol was approved by the Health Sciences Minimal Risk Institutional Review Board on November 18, 2019, with subsequent annual reviews. Recruitment began on March 6, 2020, but was suspended on March 13, 2020, due to the COVID-19 pandemic restrictions. Limited recruitment resumed on July 6, 2020. Trial status as of November 17, 2021, is as follows: 357 participants were enrolled in the study for a planned enrollment of 546 participants.ConclusionsThe new knowledge gained from this study could have wide and lasting benefits related to the integration of mHealth systems for individuals with mild to moderate AUDs. The results of this study will guide policy makers and providers toward cost-effective ways to incorporate technology in health care and community settings.Trial RegistrationClinicalTrials.gov NCT04011644; https://clinicaltrials.gov/ct2/show/NCT04011644International Registered Report Identifier (IRRID)DERR1-10.2196/31109
Highlights
OverviewThis paper describes the protocol for a randomized clinical trial testing an evidence-based alcohol use recovery app adapted for use as a prevention and harm-reduction app for individuals with mild to moderate alcohol use disorder (AUD)
Recruitment began on March 6, 2020, but was suspended on March 13, 2020, due to the COVID-19 pandemic restrictions
The new knowledge gained from this study could have wide and lasting benefits related to the integration of mobile health (mHealth) systems for individuals with mild to moderate AUDs
Summary
This paper describes the protocol for a randomized clinical trial testing an evidence-based alcohol use recovery app adapted for use as a prevention and harm-reduction app for individuals with mild to moderate alcohol use disorder (AUD). This was adapted from an app that was shown to be helpful for patients in residential treatment centers. Tula is based on Addiction-Comprehensive Health Enhancement Support System (A-CHESS), which was one of the first mHealth apps proven effective in a randomized clinical trial of patients recovering from severe AUD [8]. The original and subsequent versions of A-CHESS have a theoretical basis in self-determination theory, which holds that helping people meet three basic needs—feeling competent, feeling related to others, and feeling internally motivated and not coerced in one’s actions—improves their adaptive functioning [15]
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