Mobile Health for Alcohol Use Disorders in Clinical Practice

Alcohol Drinking Clinical Trial

Official title:

Integrating mHealth for Alcohol Use Disorders Into Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04011644
• Other study ID #: 2019-0337
• Secondary ID: R01AA024150A5320
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcoholism
• Telemedicine

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