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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
questionnaires
Sponsored by
Hôpital le Vinatier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alcohol Use Disorder

Eligibility Criteria

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

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

First Posted
January 19, 2021
Last Updated
August 11, 2022
Sponsor
Hôpital le Vinatier
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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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