Clinical trial NCT05410561: Harnessing Telemedicine to Improve Alcohol Use Disorder Outcomes in Primary Care Patients
Official title: Harnessing Telemedicine to Improve Alcohol Use Disorder Outcomes in Primary Care Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use Disorders
Substance Use
Substance Dependence
Keywords: Telehealth
Cognitive behavioral therapy
Psychoeducation
Motivational interviewing
Alcohol consumption
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-06-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to test new programs to see if they might help people manage their health and health behaviors related to alcohol use and well-being. The program sessions focus on getting to know what's important to the participants, reviewing or setting goals, and using different skills and behaviors to better manage health. The trial will help the study team learn about ways to deliver health information in a way that is useful and interesting.

This research will take place remotely (e.g., Zoom, Facetime, Phone) and participants will be randomized to the Telehealth (TeleTx) group intervention or the Enhanced Usual Care (EUC) control group. Both groups will be asked to have follow-up visits up to 12 months from the baseline visit.


Eligibility criteria: Inclusion Criteria:

* Current Diagnostic and Statistical Manual (DSM) -5 alcohol use disorder (AUD) based on alcohol symptom checklist
* An average of 3 or more drinking days per week for the past 30 days
* Have regular access to a device with video capabilities or a phone to use for study related calls

Exclusion Criteria:

* Inability to speak or understand English
* Conditions that preclude informed consent or understanding of assessment or intervention content
* Past 90-day AUD psychotherapy treatment,
* At elevated risk for complicated alcohol withdrawal
* Past-year drug injection.

Primary outcomes:
measure: Alcohol Use Disorder Treatment Initiation
timeFrame: 3 months
measure: Alcohol Use Disorder Treatment Engagement
timeFrame: 3 months
measure: Alcohol consumption days
timeFrame: 3-months
measure: Alcohol consumption days
timeFrame: 6-months
measure: Alcohol consumption days
timeFrame: 12-months
measure: Heavy drinking days
timeFrame: 3-months
measure: Heavy drinking days
timeFrame: 6-months
measure: Heavy drinking days
timeFrame: 12-months
Secondary outcomes:
measure: Total Alcohol Use Disorder Psychotherapy Treatment Attendance
timeFrame: 6-months
measure: Total Alcohol Use Disorder Psychotherapy Treatment Attendance
timeFrame: 12-months
measure: Drinking Risk Levels (Based on World Health Organization Cut-Offs)
timeFrame: Baseline to 3-months
measure: Drinking Risk Levels (Based on World Health Organization Cut-Offs)
timeFrame: Baseline to 6-months
measure: Drinking Risk Levels (Based on World Health Organization Cut-Offs)
timeFrame: Baseline to 12-months
measure: World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF)
timeFrame: Baseline to 3-months
measure: World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF)
timeFrame: Baseline to 6-months
measure: World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF)
timeFrame: Baseline to 12-months
measure: Alcohol consequences
timeFrame: Baseline to 3-months
measure: Alcohol consequences
timeFrame: Baseline to 6-months
measure: Alcohol consequences
timeFrame: Baseline to 12-months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Health Care | Veterans Affairs
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Allison Lin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Erin Bonar, PhD
role: PRINCIPAL_INVESTIGATOR
References: