Testing an mHealth System for Individuals With Mild to Moderate Alcohol Use Disorders: Protocol for a Type 1 Hybrid Effectiveness-Implementation Trial
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...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
JMIR Publications
2022-02-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2022/2/e31109 |
| _version_ | 1827858576077488128 |
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| author | Linda S Park Ming-Yuan Chih Christine Stephenson Nicholas Schumacher Randall Brown David Gustafson Bruce Barrett Andrew Quanbeck |
| author_facet | Linda S Park Ming-Yuan Chih Christine Stephenson Nicholas Schumacher Randall Brown David Gustafson Bruce Barrett Andrew Quanbeck |
| author_sort | Linda S Park |
| collection | DOAJ |
| description |
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/NCT04011644
International Registered Report Identifier (IRRID)DERR1-10.2196/31109 |
| first_indexed | 2024-03-12T12:56:09Z |
| format | Article |
| id | doaj.art-0b7235837ade430ba3054a919b6bba8b |
| institution | Directory Open Access Journal |
| issn | 1929-0748 |
| language | English |
| last_indexed | 2024-03-12T12:56:09Z |
| publishDate | 2022-02-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj.art-0b7235837ade430ba3054a919b6bba8b2023-08-28T20:49:56ZengJMIR PublicationsJMIR Research Protocols1929-07482022-02-01112e3110910.2196/31109Testing an mHealth System for Individuals With Mild to Moderate Alcohol Use Disorders: Protocol for a Type 1 Hybrid Effectiveness-Implementation TrialLinda S Parkhttps://orcid.org/0000-0001-8008-343XMing-Yuan Chihhttps://orcid.org/0000-0001-7130-1415Christine Stephensonhttps://orcid.org/0000-0002-7922-4749Nicholas Schumacherhttps://orcid.org/0000-0002-0081-4069Randall Brownhttps://orcid.org/0000-0002-5445-8119David Gustafsonhttps://orcid.org/0000-0002-0660-1902Bruce Barretthttps://orcid.org/0000-0002-3953-4718Andrew Quanbeckhttps://orcid.org/0000-0003-0762-4804 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/NCT04011644 International Registered Report Identifier (IRRID)DERR1-10.2196/31109https://www.researchprotocols.org/2022/2/e31109 |
| spellingShingle | Linda S Park Ming-Yuan Chih Christine Stephenson Nicholas Schumacher Randall Brown David Gustafson Bruce Barrett Andrew Quanbeck Testing an mHealth System for Individuals With Mild to Moderate Alcohol Use Disorders: Protocol for a Type 1 Hybrid Effectiveness-Implementation Trial JMIR Research Protocols |
| title | Testing an mHealth System for Individuals With Mild to Moderate Alcohol Use Disorders: Protocol for a Type 1 Hybrid Effectiveness-Implementation Trial |
| title_full | Testing an mHealth System for Individuals With Mild to Moderate Alcohol Use Disorders: Protocol for a Type 1 Hybrid Effectiveness-Implementation Trial |
| title_fullStr | Testing an mHealth System for Individuals With Mild to Moderate Alcohol Use Disorders: Protocol for a Type 1 Hybrid Effectiveness-Implementation Trial |
| title_full_unstemmed | Testing an mHealth System for Individuals With Mild to Moderate Alcohol Use Disorders: Protocol for a Type 1 Hybrid Effectiveness-Implementation Trial |
| title_short | Testing an mHealth System for Individuals With Mild to Moderate Alcohol Use Disorders: Protocol for a Type 1 Hybrid Effectiveness-Implementation Trial |
| title_sort | testing an mhealth system for individuals with mild to moderate alcohol use disorders protocol for a type 1 hybrid effectiveness implementation trial |
| url | https://www.researchprotocols.org/2022/2/e31109 |
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