Quality of Life in Patients With Alcohol Use Disorder (QUALIFACT)
Primary Purpose
Alcohol Use Disorder
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
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Sponsored by
About this trial
This is an interventional other trial for Alcohol Use Disorder
Eligibility Criteria
Inclusion Criteria:
- DSM-5 AUD criteria
- At least 18 years of age
- Within the 10th and 21st day of a detoxification program.
Exclusion Criteria:
- Communication difficulties (insufficient level of French, major hearing or visual impairment, major cognitive deficit)
- Under guardianship
- Under justice control
- Cannot be reached by phone
Sites / Locations
- Centre Hospitalier Le VinatierRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Quality of life of patients with AUD.
Arm Description
Patients' demographic data, socioeconomic status, physical diseases, medication use, clinical features of AUD, psychiatric variables, impulsivity, autonomy, sexual functioning, sleep quality, and cognitive functioning will be measured at baseline. The Alcohol Quality of Life Scale (AQoLS) will be completed at baseline and at 6-month follow-up. Alcohol status (relapse/abstinence) will be assessed at 6 months.
Outcomes
Primary Outcome Measures
Quality of life in patients with AUD.
Alcohol Quality of Life Scale.
Secondary Outcome Measures
Quality of life in patients with AUD 6 months after the detoxification program.
Alcohol Quality of Life Scale.
Alcohol status
Alcohol (relapse/abstinence)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04748822
Brief Title
Quality of Life in Patients With Alcohol Use Disorder
Acronym
QUALIFACT
Official Title
Factors Associated With Quality of Life in Patients With Alcohol Use Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2021 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary purpose of this study is to investigate the factors associated with quality of life of patients with alcohol use disorder (AUD) undergoing a detoxification program (cross-sectional analysis). The secondary purpose is (1) to identify the factors associated with change in quality of life between baseline and 6-month follow-up, and (2) to identify the factors associated with alcohol relapse at 6 months (longitudinal analyses).
Detailed Description
The standard DSM-5-based clinical assessment of AUD includes the number of AUD criteria (between 2 and 11) as well as various parameters related to the patterns of alcohol use (e.g., frequency of use, frequency of heavy use). In the contemporary clinical practice, more "functional" assessment tools are emerging such as quality of life, autonomy, cognitive functioning, but also other non-specific lifestyle habits, such as sleep quality and sexual functioning. These indicators are important because they define the broad impact of AUD on individual's life, and they are part of the overall rehabilitation, beyond the mere question of the relationship to alcohol. However, the determinants of quality of life of patients with AUD patients undergoing a detoxification program, and the factors associated with change in quality of life are not well identified.
This prospective cohort study will recruit 200 patients undergoing a detoxification program (home-based or in addiction services). Patients' demographic data, socioeconomic status, physical diseases, medication use, clinical features of AUD, psychiatric variables, impulsivity, autonomy, sexual functioning, sleep quality, and cognitive functioning will be measured at baseline. The Alcohol Quality of Life Scale (AQoLS) will be completed at baseline and at 6-month follow-up. Alcohol status (relapse/abstinence) will be assessed at 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Quality of life of patients with AUD.
Arm Type
Other
Arm Description
Patients' demographic data, socioeconomic status, physical diseases, medication use, clinical features of AUD, psychiatric variables, impulsivity, autonomy, sexual functioning, sleep quality, and cognitive functioning will be measured at baseline. The Alcohol Quality of Life Scale (AQoLS) will be completed at baseline and at 6-month follow-up. Alcohol status (relapse/abstinence) will be assessed at 6 months.
Intervention Type
Other
Intervention Name(s)
questionnaires
Other Intervention Name(s)
Alcohol Quality of Life Scale (AQoLS) and Alcohol status
Intervention Description
The Alcohol Quality of Life Scale (AQoLS) will be completed at baseline and at 6-month follow-up. Alcohol status (relapse/abstinence) will be assessed at 6 months.
Primary Outcome Measure Information:
Title
Quality of life in patients with AUD.
Description
Alcohol Quality of Life Scale.
Time Frame
Within the 10th and 21st day of the detoxification program (baseline assessment).
Secondary Outcome Measure Information:
Title
Quality of life in patients with AUD 6 months after the detoxification program.
Description
Alcohol Quality of Life Scale.
Time Frame
6 months after the baseline assessment.
Title
Alcohol status
Description
Alcohol (relapse/abstinence)
Time Frame
6 months after the baseline assessment.
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:
DSM-5 AUD criteria
At least 18 years of age
Within the 10th and 21st day of a detoxification program.
Exclusion Criteria:
Communication difficulties (insufficient level of French, major hearing or visual impairment, major cognitive deficit)
Under guardianship
Under justice control
Cannot be reached by phone
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin ROLLAND, MD, PhD
Phone
+33 437 915 555
Email
benjamin.rolland@ch-le-vinatier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Veronique VIAL
Phone
0033437915531
Email
veronique.vial@ch-le-vinatier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin ROLLAND, MD, PhD
Organizational Affiliation
CH LE VINATIER
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
LOUIS FERDINAND LESPINE, MD
Organizational Affiliation
CH LE VINATIER
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier Le Vinatier
City
Bron
State/Province
Auvergne Rhone Alpes
ZIP/Postal Code
69678 cedex
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ROLLAND BENJAMIN, MD,Ph
Phone
0033 437 915 555
Email
benjamin.rolland@ch-le-vinatier.fr
First Name & Middle Initial & Last Name & Degree
VIAL VERONIQUE
Phone
0033 437 915 531
Email
veronique.vial@ch-le-vinatier.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Quality of Life in Patients With Alcohol Use Disorder
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