search
Back to results

Leveraging Virtual Care Strategies to Improve Access and Treatment for Individuals With Alcohol Use Disorders

Primary Purpose

Alcohol Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone Engagement
Portal Engagement
MI-CBT
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring Telehealth

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • AUD
  • past month heavy alcohol use
  • internet access
  • phone access
  • able to provide informed consent

Exclusion Criteria:

  • inability to speak or understand English
  • conditions precluding informed consent or understanding of intervention or assessment content
  • recent AUD treatment
  • history of or at risk for complex alcohol withdrawal
  • involvement in another ongoing study for alcohol/mental health/substance use treatment
  • PI discretion

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Arm A

Arm B

Arm C

Arm D

Arm E

Arm F

Arm Description

First stage intervention: Telephone engagement Second stage intervention: Telehealth Motivational Interviewing-Cognitive Behavioral Therapy (MI-CBT program)

First stage intervention: Telephone engagement Second stage intervention: Enhanced Telephone engagement

First stage intervention: Telephone engagement Second stage intervention: Not Applicable (NA), proceed directly to follow up

First stage intervention: Portal Engagement Second stage intervention: NA, proceed directly to follow up

First stage intervention: Portal Engagement Second stage intervention: Enhanced Portal Engagement

First stage intervention: Portal Engagement Second stage intervention: Telehealth MI-CBT program

Outcomes

Primary Outcome Measures

AUD Treatment Initiation
% of patients who initiate psychotherapy treatment
AUD Treatment Engagement
% of patients who attend at least 2 psychotherapy treatment sessions
Alcohol consumption days
% of days of alcohol consumption as measured by the Timeline Follow Back Interview
Alcohol consumption days
% of days of alcohol consumption as measured by the Timeline Follow Back Interview
Alcohol consumption days
% of days of alcohol consumption as measured by the Timeline Follow Back Interview
Heavy drinking days
% of days of heavy drinking as measured by the Timeline Follow Back Interview
Heavy drinking days
% of days of heavy drinking as measured by the Timeline Follow Back Interview
Heavy drinking days
% of days of heavy drinking as measured by the Timeline Follow Back Interview

Secondary Outcome Measures

Full Information

First Posted
October 21, 2022
Last Updated
August 7, 2023
Sponsor
University of Michigan
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
search

1. Study Identification

Unique Protocol Identification Number
NCT05594238
Brief Title
Leveraging Virtual Care Strategies to Improve Access and Treatment for Individuals With Alcohol Use Disorders
Official Title
Leveraging Virtual Care Strategies to Improve Access and Treatment for Individuals With Alcohol Use Disorders (AUD)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2023 (Actual)
Primary Completion Date
September 10, 2026 (Anticipated)
Study Completion Date
September 10, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
Keywords
Telehealth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Participants are first randomly assigned to two interventions: either Telephone Engagement or Portal Engagement. Participants who do not meet the criteria for response at the post-test will be re-randomized into either enhanced first stage or a Telehealth MI-CBT program.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
First stage intervention: Telephone engagement Second stage intervention: Telehealth Motivational Interviewing-Cognitive Behavioral Therapy (MI-CBT program)
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
First stage intervention: Telephone engagement Second stage intervention: Enhanced Telephone engagement
Arm Title
Arm C
Arm Type
Active Comparator
Arm Description
First stage intervention: Telephone engagement Second stage intervention: Not Applicable (NA), proceed directly to follow up
Arm Title
Arm D
Arm Type
Active Comparator
Arm Description
First stage intervention: Portal Engagement Second stage intervention: NA, proceed directly to follow up
Arm Title
Arm E
Arm Type
Active Comparator
Arm Description
First stage intervention: Portal Engagement Second stage intervention: Enhanced Portal Engagement
Arm Title
Arm F
Arm Type
Active Comparator
Arm Description
First stage intervention: Portal Engagement Second stage intervention: Telehealth MI-CBT program
Intervention Type
Behavioral
Intervention Name(s)
Telephone Engagement
Intervention Description
Brief phone session with a study counselor.
Intervention Type
Behavioral
Intervention Name(s)
Portal Engagement
Intervention Description
Access to a virtual portal where participant messages with study counselors.
Intervention Type
Behavioral
Intervention Name(s)
MI-CBT
Intervention Description
8 one-on-one sessions done over the phone or video chat with a study counselor
Primary Outcome Measure Information:
Title
AUD Treatment Initiation
Description
% of patients who initiate psychotherapy treatment
Time Frame
4-months post-enrollment
Title
AUD Treatment Engagement
Description
% of patients who attend at least 2 psychotherapy treatment sessions
Time Frame
4-months post-enrollment
Title
Alcohol consumption days
Description
% of days of alcohol consumption as measured by the Timeline Follow Back Interview
Time Frame
4-months post-enrollment
Title
Alcohol consumption days
Description
% of days of alcohol consumption as measured by the Timeline Follow Back Interview
Time Frame
8-months post-enrollment
Title
Alcohol consumption days
Description
% of days of alcohol consumption as measured by the Timeline Follow Back Interview
Time Frame
12-months post-enrollment
Title
Heavy drinking days
Description
% of days of heavy drinking as measured by the Timeline Follow Back Interview
Time Frame
4-months post-enrollment
Title
Heavy drinking days
Description
% of days of heavy drinking as measured by the Timeline Follow Back Interview
Time Frame
8-months post-enrollment
Title
Heavy drinking days
Description
% of days of heavy drinking as measured by the Timeline Follow Back Interview
Time Frame
12-months post-enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: AUD past month heavy alcohol use internet access phone access able to provide informed consent Exclusion Criteria: inability to speak or understand English conditions precluding informed consent or understanding of intervention or assessment content recent AUD treatment history of or at risk for complex alcohol withdrawal involvement in another ongoing study for alcohol/mental health/substance use treatment PI discretion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lyndsay Chapman
Phone
(734) 764-7936
Email
lych@umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Mobley
Email
lmobley@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin E Bonar
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Mobley
Phone
734-232-0298
Email
lmobley@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Erin Bonar
First Name & Middle Initial & Last Name & Degree
Lewei (Allison) Lin

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Consistent with sponsor requirements, de-identified data will be shared with the NIAAA Data Repository, if participants agree.

Learn more about this trial

Leveraging Virtual Care Strategies to Improve Access and Treatment for Individuals With Alcohol Use Disorders

We'll reach out to this number within 24 hrs