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Quality of Life in Patients With Alcohol Use Disorder (QUALIFACT)

H

Hôpital le Vinatier

Status

Completed

Conditions

Alcohol Use Disorder

Treatments

Other: questionnaires

Study type

Interventional

Funder types

Other

Identifiers

NCT04748822
2020-A02853-36

Details and patient eligibility

About

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).

Full 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.

Enrollment

167 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

167 participants in 1 patient group

Quality of life of patients with AUD.
Other group
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.
Treatment:
Other: questionnaires

Trial contacts and locations

1

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Central trial contact

Veronique VIAL; Benjamin ROLLAND, MD, PhD

Data sourced from clinicaltrials.gov

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