- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05393544
Digitally Assisted Recovery Coach
May 23, 2022 updated by: Joji Suzuki, MD, Brigham and Women's Hospital
Digitally Assisted Virtual Recovery Coach to Improve Inpatient Alcohol Withdrawal Management: A Proof-of-concept Pilot Study
The aims of this proof-of-concept study are to determine the feasibility of 1) using a smartphone app ("Lifeguard") to facilitate engagement with a peer recovery coach, 2) monitoring post-detox using a modified Brief Addiction Monitor, and 3) assessing linkage to care post-detox.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02130
- Brigham and Women's Faulkner Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults aged 18 to 65
- Diagnosis of DSM-5 alcohol use disorder
- Admitted to Brigham and Women's Faulkner Hospital (BWF) inpatient Addiction Recovery Program to treat alcohol withdrawal
- Own either an iOS or Android smartphone device
- Have an active email address
- English speaking
Exclusion Criteria:
- Inability to provide informed consent due to delirium or other cognitive impairments
- Current psychosis, suicidality or homicidality
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention
The intervention utilizes an existing care coordination smartphone app to allow participants to engage with a recovery coach during and after an inpatient admission to an inpatient withdrawal management facility (i.e.
detox).
|
The certified peer recovery coach utilized an existing care coordination smartphone app to provide support to the patient during and after an inpatient detoxification treatment for alcohol use disorder.
The coach utilized the telephone or text messages to send daily motivational messages, remind about upcoming appointments, and checked-in if responses were concerning.
Follow-up by the coach continued for 30 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of coach engagement
Time Frame: 30 days
|
The proportion and the number of days of participants engaging with the coach during and after detoxification.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of monitoring clinical status
Time Frame: 30 days
|
The proportion and the number of days of participants responding to prompts during and after detoxification.
|
30 days
|
Linkage to care
Time Frame: 30 days
|
The proportion of participants successfully linking to care after discharge.
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 1, 2021
Primary Completion (ACTUAL)
April 1, 2022
Study Completion (ACTUAL)
May 15, 2022
Study Registration Dates
First Submitted
May 23, 2022
First Submitted That Met QC Criteria
May 23, 2022
First Posted (ACTUAL)
May 26, 2022
Study Record Updates
Last Update Posted (ACTUAL)
May 26, 2022
Last Update Submitted That Met QC Criteria
May 23, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021P000731
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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