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Clinical Trials/NCT04748822
NCT04748822
Completed
Not Applicable

Factors Associated With Quality of Life in Patients With Alcohol Use Disorder

Hôpital le Vinatier1 site in 1 country167 target enrollmentMarch 25, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alcohol Use Disorder
Sponsor
Hôpital le Vinatier
Enrollment
167
Locations
1
Primary Endpoint
Quality of life in patients with AUD.
Status
Completed
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 25, 2021
End Date
January 21, 2025
Last Updated
9 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Hôpital le Vinatier
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Quality of life in patients with AUD.

Time Frame: Within the 10th and 21st day of the detoxification program (baseline assessment).

Alcohol Quality of Life Scale.

Secondary Outcomes

  • Quality of life in patients with AUD 6 months after the detoxification program.(6 months after the baseline assessment.)
  • Alcohol status(6 months after the baseline assessment.)

Study Sites (1)

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