Clinical trial NCT04748822: Quality of Life in Patients With Alcohol Use Disorder
Official title: Factors Associated With Quality of Life in Patients With Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort study
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Quality of life in patients with AUD.
timeFrame: Within the 10th and 21st day of the detoxification program (baseline assessment).
Secondary outcomes:
measure: Quality of life in patients with AUD 6 months after the detoxification program.
timeFrame: 6 months after the baseline assessment.
measure: Alcohol status
timeFrame: 6 months after the baseline assessment.
Other outcomes:
Locations:
city: Bron
country: France
facility: Centre Hospitalier Le Vinatier
state: Auvergne Rhone Alpes
Study officials:
affiliation: CH LE VINATIER
name: Benjamin ROLLAND, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CH LE VINATIER
name: LOUIS FERDINAND LESPINE, MD
role: STUDY_DIRECTOR
References: