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Alcohol Brief Counseling in Primary Care

Primary Purpose

Alcohol Drinking

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
AUDIT brief intervention
Pamphlet on alcohol use
Sponsored by
Pontificia Universidad Catolica de Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Drinking focused on measuring alcohol drinking, hazardous alcohol use, risky alcohol consumption, heavy alcohol consumption

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • AUDIT score between 8 and 15
  • Able to read
  • Haven't received a similar intervention in the last 3 months

Exclusion Criteria:

  • Clients in treatment for alcohol use disorder
  • Alcohol use treatment seekers
  • Pregnant woman
  • Severe physical or psychiatric pathology not stable

Sites / Locations

  • CESFAM Juan Pablo II
  • CESFAM San Alberto Hurtado
  • CESFAM Madre Teresa de Calcuta
  • CESFAM Barros Luco
  • CESFAM Recreo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Brief intervention

Control group

Arm Description

AUDIT brief intervention

Pamphlet on alcohol use

Outcomes

Primary Outcome Measures

AUDIT score
Total of questions 1 to 10 (minimum 0, maximum 40)

Secondary Outcome Measures

AUDIT-C score
Total of questions 1 to 3 (minimum 0, maximum 12)

Full Information

First Posted
December 28, 2015
Last Updated
May 20, 2019
Sponsor
Pontificia Universidad Catolica de Chile
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1. Study Identification

Unique Protocol Identification Number
NCT02642757
Brief Title
Alcohol Brief Counseling in Primary Care
Official Title
Effectiveness of a Brief Intervention for Reducing the Alcohol Use in Risky Users Delivered by Paramedics in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
December 15, 2015 (undefined)
Primary Completion Date
July 30, 2017 (Actual)
Study Completion Date
July 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pontificia Universidad Catolica de Chile

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates the effectiveness of a brief intervention for the reduction of alcohol use among risky alcohol users in primary care delivered by paramedics. Half of the participants will receive a brief intervention and half will receive written guidelines on safe alcohol use.
Detailed Description
Randomized controlled trial with a pragmatic emphasis undertaken in real world primary care. The brief intervention has been designed and piloted by the mental health team at the Chilean ministry of health, as also the written support material. This intervention is the same that is being implemented national wide. The implementation will include training of the paramedics, and then an accreditation session with a simulated participant in a double sided mirror. Randomization will take place on site using a opaque envelope. The sequence will be keep on site in a secured box. Data will be registered by the same person delivering the intervention and kept safe at the clinical sites. Once a month the data will be physically transferred to the operational center at the San Joaquin site of the Catholic University of Chile. Bimonthly visits will be performed to the centers by a member of the team to assure that the protocol is being followed and data audit. The participants will receive an economical incentive for the follow up visit. Participants will be reached throw telephone at least twice to schedule that visit. If not possible, a telephonic outcome assessment or a domiciliary visit will be performed to minimize the lost in follow up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking
Keywords
alcohol drinking, hazardous alcohol use, risky alcohol consumption, heavy alcohol consumption

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
342 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief intervention
Arm Type
Experimental
Arm Description
AUDIT brief intervention
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Pamphlet on alcohol use
Intervention Type
Behavioral
Intervention Name(s)
AUDIT brief intervention
Intervention Description
Intervention will be provided following the Chilean ministry of health implementation manual on the AUDIT associated brief intervention. The pamphlet on alcohol use will be provided to participants.
Intervention Type
Other
Intervention Name(s)
Pamphlet on alcohol use
Intervention Description
Only the pamphlet on alcohol use will be provided (the same received by participants on the intervention group). This is not an active intervention based on the current literature.
Primary Outcome Measure Information:
Title
AUDIT score
Description
Total of questions 1 to 10 (minimum 0, maximum 40)
Time Frame
6 months post brief intervention
Secondary Outcome Measure Information:
Title
AUDIT-C score
Description
Total of questions 1 to 3 (minimum 0, maximum 12)
Time Frame
6 months post brief intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: AUDIT score between 8 and 15 Able to read Haven't received a similar intervention in the last 3 months Exclusion Criteria: Clients in treatment for alcohol use disorder Alcohol use treatment seekers Pregnant woman Severe physical or psychiatric pathology not stable
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Barticevic, MD
Organizational Affiliation
Instructor Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
CESFAM Juan Pablo II
City
Santiago
State/Province
Metropolitana
Country
Chile
Facility Name
CESFAM San Alberto Hurtado
City
Santiago
State/Province
Puente Alto
ZIP/Postal Code
8181297
Country
Chile
Facility Name
CESFAM Madre Teresa de Calcuta
City
Santiago
State/Province
Puente Alto
Country
Chile
Facility Name
CESFAM Barros Luco
City
Santiago
State/Province
San Miguel
Country
Chile
Facility Name
CESFAM Recreo
City
Santiago
State/Province
San Miguel
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34130748
Citation
Barticevic NA, Poblete F, Zuzulich SM, Rodriguez V, Quevedo D, Sena BF, Bradshaw L. A Health Technician-delivered Brief Intervention linked to AUDIT for reduction of alcohol use in Chilean primary care: a randomized controlled trial. Addict Sci Clin Pract. 2021 Jun 15;16(1):39. doi: 10.1186/s13722-021-00248-4.
Results Reference
derived

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Alcohol Brief Counseling in Primary Care

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