Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04011644
Other study ID # 2019-0337
Secondary ID R01AA024150A5320
Status Completed
Phase N/A
First received
Last updated
Start date March 23, 2020
Est. completion date January 22, 2024

Study information

Verified date January 2024
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the impact on risky drinking days and quality of life for patients with alcohol use disorder among patients who use a mobile health smart phone application. A third of the participants will receive access to the smart phone app without any monitoring; a third of the participants will receive access to the smart phone app monitored by and connected with a peer mentor; a third will receive access to the smart phone app monitored by and connected with a health coach who works within a healthcare system.


Description:

Patients in the trial will be given versions of an evidence-based mobile-health (mHealth) system (re-design based on A-CHESS) that is delivered using different implementation strategies according to study group. A-CHESS has more than 18 services designed to improve social relatedness, coping competence, and intrinsic motivation. The following describes key A-CHESS services that will be tested in the current study: - Welcome message - patients write why they are choosing to reduce their drinking. - Coping with Cravings - the system automatically notifies nearby pre-approved friends, family, and peers, who can respond to a request for support. The patient can also be linked to positive activities, such as suggested games to download and play and audio/video-based relaxation recordings. - Monitoring functionality- self-assessment measures, record of A-CHESS use, and prediction of the patient's likelihood of having a heavy drinking episode in the next week. A-CHESS sends patients with worrisome responses suggestions of coping skills, online peer support, healthy events, etc. With patient permission, a prediction of high-risk can be shared with others in a position to provide support. - Triage and feedback functionality is designed to derail a setback in goal attainment, giving the patient 'just in time,' tailored support by linking patients to relevant A-CHESS resources or individuals (depending on group assignment). - The Specialist Report, harvests clinically relevant data from A-CHESS and presents it to a peer mentor (in the peer-supported group) or a health coach (in the clinically integrated group), at which point they may intervene with patients (e.g., through texting in A-CHESS). - Facilitated discussion groups (in the clinically integrated group.) Discussions are monitored daily by an A-CHESS coach. - Library - information about healthy lifestyle choices, calendar of healthy events in the area, etc. - Drink tracker and report feature - patients to self-monitor their drinking and each week see a summary of how they did the past week. - Profiles about why patients want to reduce their drinking. All patients enrolled in the study will participate in a 3-month intervention period followed by a 9-month follow-up period, for a total of 12 months. All patient will undergo a 72-hour run-in period. After 72 hours, patients who remain in the study will be randomized to one of the following groups and receive the appropriate access to features. One group will operate independently; one group will have help from a peer-mentor; one group will be connected to a healthcare system by a health coach.


Recruitment information / eligibility

Status Completed
Enrollment 558
Est. completion date January 22, 2024
Est. primary completion date October 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 100 Years
Eligibility Inclusion Criteria: - are 21+ years old, - interested in learning about ways to reduce drinking, - willing to download and use A-CHESS, - lives in within the geographical boundaries of the UW Health system - be able to understand and sign an electronic consent form in English, - own an Apple or android smart phone, - meets the criteria for at risk drinking on the AUDIT screening, - responds yes to at least one question on the Alcohol Use Disorder (AUD) Diagnostic and Statistical Manual-5 survey, and - indicates in the past week they have had at least 7 drinks and 3 on a single day (women), or had at least 14 drinks and 4 on a single day (men). Exclusion Criteria: - has a severe alcohol use disorder (yes to 6+ items on the Alcohol Use Disorder (AUD) Diagnostic and Statistical Manual-5) - have a current psychotic disorder - have an acute medical problem requiring immediate hospitalization - have a known terminal illness

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
A-CHESS self-monitored
Patients have access to a smart phone app that provides information on tips on how to reduce drinking, a drink tracker, a journal, discussion boards, and private messaging with a research team member. Patients set weekly goals related to their drinking, reassess each week, and set a new goal for the upcoming week.
A-CHESS peer-supported
Patients have access to a smart phone app that provides information on tips on how to reduce drinking, a drink tracker, a journal, discussion boards, and private messaging with a counselor. Patients set weekly goals related to their drinking, reassess each week, and set a new goal for the upcoming week.
A-CHESS clinically-integrated
Patients have access to a smart phone app that provides information on tips on how to reduce drinking, a drink tracker, a journal, discussion boards, and private messaging with a health coach. Patients set weekly goals related to their drinking, reassess each week, and set a new goal for the upcoming week.

Locations

Country Name City State
United States UW Health at the American Center Madison Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
University of Wisconsin, Madison National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of risky drinking days The number of days patients reported as risky drinking days. For women and men over 65 years old, risky drinking is defined as 3 or more drinks on any single day and 7 or more drinks per week. For men under 65 years old, it is defined as 4 or more drinks on any single day and 14 or more drinks per week. 12 months
Secondary Number of patients who are willing to share data Patients in the clinically-integrated arm will have the option to share their data collected by A-CHESS with the health coach. Knowing how many patients are willing to share data about their drinking will allow researchers to make hypothesis about how effective A-CHESS can be in a healthcare setting. 12 months
Secondary Number of healthcare services used in the past 6 months Patients will be asked to indicate if they have used medical services in the past 6 months and list what services they used. Researchers will include this in the cost-effectiveness analysis. 12 months
Secondary Cost of implementation of each intervention arm in US dollars The cost (in US dollars) of the intervention will be calculated to determine cost-effectiveness of the study. up to 3 years
Secondary Number of patient risk factors assessed by a revised Brief Alcohol Monitor Patients will take a revised Brief Alcohol Monitor survey that will ask about risk factors that will then be used to predict setbacks. 12 months
Secondary Number of days health coach/other clinician used the A-CHESS dashboard The number of days the health coach or other clinicians used the A-CHESS dashboard. This will help assess how useful the specialist report was to clinicians. 36 months
Secondary Score of Alcohol Use Disorders Identification Test (AUDIT) screening tool The AUDIT screening tool will be used to assess patient alcohol severity. For women, the scoring is as follows: 0-3 = low-risk; 4-12 = risky; 13-19 = harmful; 20+ = severe. For men, the scoring is as follows: 0-4 = low-risk; 5-14 = risky; 15-19 = harmful; 20+ = severe.
The screening tool consists of 10 questions with 5 possible answers. Each answer has a score value ranging from 0-5.
12 months
Secondary Score of the Diagnostic and Statistical Manual- 5 Alcohol use disorder (AUD) severity The Diagnostic and Statistical Manual of Mental Disorders 5th edition criteria of alcohol use disorder will be used to assess patient's alcohol use disorder severity. The severity of the AUD is defined as 1) mild: 2 to 3 symptoms; 2) moderate: 4 to 5 symptoms; 3) severe: 6+ symptoms. 12 months
Secondary Score of relatedness as assessed by the CHESS Bonding Scale The study will assess how connected patients feel with others. A-CHESS is based on relatedness. The more connected patients feel with others, the more less risky drinking days patients will have. Patients will be asked 5 questions on their relationships with others. Patients can respond on a 1-5 scale corresponding to "Never" to "Nearly Always", respectively. Higher relatedness scores typically correspond with less alcohol use. 12 months
Secondary Score of competence as assessed by the Perceived competence scale (PCS) The study will assess how patients perceive their ability to control and reduce their drinking. Patients typically drink less when they feel more confident about controlling their drinking. Patients will be asked 4 questions about their confidence to use alcohol responsibly in different situations. Patients can indicate their confidence on a 1-7 scale corresponding to "Not at all" to "Very true", respectively. Higher scores typically correspond to less alcohol use. 12 months
Secondary Score of autonomous motivation as assessed by revised Treatment Self Regulation Questionnaire The study will asses how motivated patients are by their own goals. Patients typically drink less when they, themselves, want to reduce their alcohol. Patients will be asked 6 questions about why they will reduce their alcohol use and can indicate how much they identify with each statement on a 1-5 scale corresponding to "Not true" to "Very true", respectively. Higher scores typically correspond to less alcohol use. 12 months
Secondary Time of A-CHESS used The time patients spent using A-CHESS will be assessed. up to 3 years
Secondary Number of setback status triggered by A-CHESS The patient's ability to meet their weekly goal will be assessed. When patients are not on track to meet their weekly goal a setback alert will be triggered. 12 months
Secondary Variables used for predictive setback status The variables that help predict a setback will be assessed and reported. Knowing the variables for setbacks will help researchers program A-CHESS to better predict when patients are likely to have a setback. up to 3 years
Secondary Number of response statuses addressed Clinicians and patients will be alerted when the system predicts that they may have a setback. This allows researchers to know how useful patients and health coaches found the alerts. up to 3 years
Secondary Score of overall quality of life as assessed by Patient Reported Outcomes Measurement Information System (PROMIS) Global-10 The Patient Reported Outcomes Measurement Information System Global-10 form will be used to assess quality of life. It consists of 10 questions that assess general domains of health and functioning including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. Each question will ask patients to indicate their health of each domain on a scale of 1-5, which corresponds to poor to excellent. 2 additional questions related to impact of COVID-19 on participant's physical and mental health will be asked. Higher scores correspond to better overall quality of life. 12 months
Secondary Pages viewed on A-CHESS The number of pages viewed by patients and health coaches will be assessed know how useful patients found different content. up to 3 years
Secondary Number of patient protection factors assessed by a revised Brief Alcohol Monitor Patients will take a revised Brief Alcohol Monitor survey that will ask about protection factors that will then be used to predict setbacks. 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT05414344 - A Brief Intervention for Alcohol Users With Interpersonal Trauma N/A
Completed NCT05521906 - Evaluation of PRYSHM for LGBTQIA2S+ Youth N/A
Not yet recruiting NCT04786587 - Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
Withdrawn NCT04659278 - Endourage Complete Spectrum Oral Mucosal Drops (OMD) in Adults Desiring a Reduction in Ethanol Use N/A
Not yet recruiting NCT03632408 - Hangover and Residual Zopiclone Effect on Spatial Perception Phase 1
Completed NCT02718508 - An e-Parenting Skills Intervention to Decrease Injured Adolescents' Alcohol Use N/A
Active, not recruiting NCT02629679 - Sports, Education and Consumption of Substances in Adolescents N/A
Completed NCT02945371 - Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life N/A
Completed NCT01553136 - Varenicline Treatment of Alcohol Dependence in Smokers Phase 2
Completed NCT01442753 - Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth N/A
Completed NCT01081119 - Brief Voluntary Alcohol and Drug Intervention for Middle School Youth Phase 2
Completed NCT00289965 - Substance Use Risk Education (SURE) Project Phase 2
Completed NCT04510116 - Adults In The Making Prevention Trial N/A
Completed NCT00506753 - Motivation and Skills for Delta-9-tetrahydrocannabinol/Ethanol (THC/ETOH+) Teens in Jail N/A
Recruiting NCT05288790 - Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT Phase 2
Recruiting NCT05620849 - Young Adult Education on Alcohol & Health N/A
Recruiting NCT04054466 - Nursing Counseling to the Change of Behavior of Alcohol Consumption in Patients in HAART N/A
Recruiting NCT03588754 - Does Propranolol, a Beta Blocker, Attenuate Stress-Induced Drinking? Phase 2
Recruiting NCT06074341 - TeleHealth Resources for IndiVidualizEd Goals (THRIVE) in Alcohol Recovery Study N/A
Terminated NCT04596267 - Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers Phase 1