Effectiveness of an Intervention in Patients With Excessive Alcohol Consumption

NCT04811729 | Completed

• 1 other identifier: ALCO-AP20
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

Brief Summary

• Main objective: to verify the effectiveness of a brief intervention, based on the motivational interview (MI), in patients with excessive alcohol consumption assisted in Primary Care (PC).
• Design: a multicenter, randomized, cluster-controlled clinical trial with two parallel arms. PC professionals will be randomized to one of the two study groups: 1) Experimental Group (EG): MI-based approach; 2) Control group (CG): usual care. At least 50 family doctors, residents and nurses will participate, recruiting PC patients (n = 394). GE intervention: Training program to acquire specific skills on approaching risky alcohol consumption. It will consist of a workshop, with two video recordings of consultations with simulated standardized patients, before and after it, with each participant receiving formative feedback at the end. -Intervention GC: medical advice that is usually performed in these patients. To measure the knowledge and attitude of professionals in dealing with patients with alcohol consumption, they will fill out a validated questionnaire. In addition, expert evaluators, after viewing the video recordings, will fill out a check-list to check the attitude of each professional, using the EVEM Scale. -Study population: patients ≥14 years of age with risky consumption, detected by the professional in health centers in the province of Córdoba (Spain). Sample size: Assuming a loss rate of 5%, and the "cluster design effect", the number of subjects to be recruited is estimated at 394 (197 / group). Intervention control mechanism: each participant will be audio-recorded with a real patient in a randomly chosen visit, evaluating her skills with the EVEM scale. The follow-up period for each patient will be 12 months, with 4 visits (initial, per month, 3 months, and 6 months) and 4 interleaved telephone contacts. The main outcome variable will be the level of self-reported alcohol consumption and the AUDIT questionnaire score. -Statistical analysis by intention to treat. Descriptive analysis and initial comparability of the groups will be carried out, and the effect of the intervention (dependent variable: abstinence or consumption reduction and AUDIT score) will be evaluated through bivariate and multivariate analysis.

Conditions

Alcohol Consumption; Alcohol Use Disorder

Keywords

Alcohol use disorder

Outcome Measures

Primary Outcomes (3)

• Alcohol consumption

  Self-reported alcohol consumption level

  12 months

• AUDIT

  Alcohol Use Disorder Identification Test (AUDIT) questionnaire score

  12 months

• Alcohol Use Disorder Identification Test (AUDIT) questionnaire score

  Tool designed to identify risky alcohol consumption and comprises 10 questions divided into 3 conceptual domains. The first domain assesses recent alcohol consumption and contains 3 questions (frequency of consumption, typical amount and frequency of heavy consumption). The second domain assesses symptoms of dependence through 3 items (loss of control over consumption, increased relevance of consumption and morning consumption) and finally the third domain assesses harmful alcohol consumption through 4 questions (Feeling of guilt after consumption , memory gaps, alcohol-related injuries and environmental concern about consumption). A result equal to or greater than 8 is considered indicative of risky and harmful consumption, as well as a possible dependence on alcohol.

  12 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

Intervention based on the Motivational Interview, previously receiving a training program

Behavioral: Motivational interview

Control Group

ACTIVE COMPARATOR

Usual care based on a health counci

Behavioral: Medical advice

Interventions

Motivational interview BEHAVIORAL

The participants will apply an approach based on the Motivational Interview (Rollnick, 2008) in patients with excessive alcohol consumption, previously receiving a training program

Experimental Group

Medical advice BEHAVIORAL

Usual care

Control Group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Hospital Universitario Reina Sofia de Cordoba: lead
• Maimonides Institute for Biomedical Research of Cordoba (IMIBIC): collaborator
• Progress and Health Foundation: collaborator
• Córdoba and Guadalquivir Health District: collaborator

Study Sites (1)

Distrito sanitario Córdoba y Guadalquivir

Córdoba, 14011, Spain

Location

MeSH Terms

Conditions

Alcohol Drinking; Alcoholism

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jose Angel Fernández García, Doctor

  Andaluz Health Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor in medicine. Collaborating researcher of the project

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 23, 2021
• Study Start: February 18, 2022
• Primary Completion: April 1, 2023
• Study Completion: July 30, 2023
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)