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Mobile Health for Alcohol Use Disorders in Clinical Practice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04011644
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : March 27, 2020
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief 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.

Condition or disease Intervention/treatment Phase
Alcohol Drinking Telemedicine Behavioral: A-CHESS self-monitored Behavioral: A-CHESS peer-supported Behavioral: A-CHESS clinically-integrated Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 546 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study will have rolling enrollment over two years. Patients will be enrolled and randomized to one of three interventions for 12 months.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Integrating mHealth for Alcohol Use Disorders Into Clinical Practice
Actual Study Start Date : March 23, 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Active Comparator: Self monitored
Patients of this group will continue receiving regular care from their physician with no interference from the two experimental groups. Patient subjects will download the app on their Android or Apple smart phone that will direct them to external information hosted on the internet that may help reduce their drinking (e.g., NIAAA resources). For the first 12 weeks, once a week patients can set a weekly goal related to their alcohol use or other health related behaviors (e.g., "I will only drink on Friday this week."). At the end of the week subjects will be prompted to take a weekly survey, which will include questions such as a variation of the brief alcohol monitor (BAM) and timeline followback. Patients will then receive feedback on the amount of drinks they had compared to their goal. Then the patient will set a new goal for the following week. Patients will complete quarterly surveys on the A-CHESS app to assess study outcomes.
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.

Experimental: Peer supported
Patients will be asked to take the same surveys and have the access to the same information as the self-monitoring group. Patient subjects in this group will have access to discussion boards where they can talk to one another and have the ability to share and see stories of other patients. The only involvement of someone other than patients themselves in the peer-supported group will be by a sponsor (i.e., a dedicated user from the area with a sustained history of successful alcohol reduction). The sponsor will participate in discussion groups and encourage use of the system. Patient-reported feedback will be presented directly to the patient.
Behavioral: 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.

Experimental: Clinically integrated
Patients in the clinically integrated group will receive the same intervention as the peer-supported group aside from three differences: 1) patients have the option to share selected elements of their app data with the University of Wisconsin (UW) Health health coach, 2) the health coach will replace the role of the sponsor in the peer-support group, and 3) patients will have the option to attend an initial 60- to 90-minute and two 30-minute follow-up consultations with the health coach in-person, via phone, or via video chat.
Behavioral: 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.




Primary Outcome Measures :
  1. Number of risky drinking days [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Number of patients who are willing to share data [ Time Frame: 12 months ]
    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.

  2. Number of healthcare services used in the past 6 months [ Time Frame: 12 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.

  3. Cost of implementation of each intervention arm in US dollars [ Time Frame: up to 3 years ]
    The cost (in US dollars) of the intervention will be calculated to determine cost-effectiveness of the study.

  4. Number of patient risk factors assessed by a revised Brief Alcohol Monitor [ Time Frame: 12 months ]
    Patients will take a revised Brief Alcohol Monitor survey that will ask about risk factors that will then be used to predict setbacks.

  5. Number of days health coach/other clinician used the A-CHESS dashboard [ Time Frame: 36 months ]
    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.

  6. Score of Alcohol Use Disorders Identification Test (AUDIT) screening tool [ Time Frame: 12 months ]

    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.


  7. Score of the Diagnostic and Statistical Manual- 5 Alcohol use disorder (AUD) severity [ Time Frame: 12 months ]
    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.

  8. Score of relatedness as assessed by the CHESS Bonding Scale [ Time Frame: 12 months ]
    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.

  9. Score of competence as assessed by the Perceived competence scale (PCS) [ Time Frame: 12 months ]
    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.

  10. Score of autonomous motivation as assessed by revised Treatment Self Regulation Questionnaire [ Time Frame: 12 months ]
    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.

  11. Time of A-CHESS used [ Time Frame: up to 3 years ]
    The time patients spent using A-CHESS will be assessed.

  12. Number of setback status triggered by A-CHESS [ Time Frame: 12 months ]
    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.

  13. Variables used for predictive setback status [ Time Frame: up to 3 years ]
    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.

  14. Number of response statuses addressed [ Time Frame: up to 3 years ]
    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.

  15. Score of overall quality of life as assessed by Patient Reported Outcomes Measurement Information System (PROMIS) Global-10 [ Time Frame: 12 months ]
    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. Higher scores correspond to better overall quality of life.

  16. Pages viewed on A-CHESS [ Time Frame: up to 3 years ]
    The number of pages viewed by patients and health coaches will be assessed know how useful patients found different content.

  17. Number of patient protection factors assessed by a revised Brief Alcohol Monitor [ Time Frame: 12 months ]
    Patients will take a revised Brief Alcohol Monitor survey that will ask about protection factors that will then be used to predict setbacks.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • are 18+ years old,
  • interested in learning about ways to reduce drinking,
  • willing to download and use A-CHESS,
  • have a previously created,
  • active UW Health medical record,
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011644


Contacts
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Contact: Christine Stephenson, PhD 608-263-4492 cstephenson@wisc.edu
Contact: Nick Schumacher, BS 608-262-8312 ndschumacher@wisc.edu

Locations
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United States, Wisconsin
UW Health at the American Center Recruiting
Madison, Wisconsin, United States, 53718
Contact: Katie Schwartz, BSN       KSchwartz@uwhealth.org   
Sponsors and Collaborators
University of Wisconsin, Madison
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Andrew Quanbeck, PhD University of Wisconsin, Madison
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04011644    
Other Study ID Numbers: 2019-0337
R01AA024150 ( U.S. NIH Grant/Contract )
A532007 ( Other Identifier: UW, Madison )
SMPH/FAMILY MED/RES GRANTS ( Other Identifier: UW, Madison )
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data collected during the trial, after deidentification will be available to researchers for independent verification of study outcomes or to conduct subsequent clinical research, whose proposed use of the data has been approved by an independent review committee identified for this purpose.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Beginning 9 months after publication of primary outcomes, and ending 3 years following publication.
Access Criteria: Proposals should be directed to PI Andrew Quanbeck at arquanbe@wisc.edu. If approved after review by regulatory counsel, requestors will enter into a formal data sharing agreement. Data will be shared via encrypted single-user file transmission protocol.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
implementation
alcohol drinking
mHealth
wellness
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders