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Alcohol Brief Counseling in Primary Care

This study is currently recruiting participants.
Verified October 2016 by Pontificia Universidad Catolica de Chile
Sponsor:
ClinicalTrials.gov Identifier:
NCT02642757
First Posted: December 30, 2015
Last Update Posted: October 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile
  Purpose
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.

Condition Intervention
Alcohol Drinking Behavioral: AUDIT brief intervention Other: Pamphlet on alcohol use

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of a Brief Intervention for Reducing the Alcohol Use in Risky Users Delivered by Paramedics in Primary Care

Resource links provided by NLM:


Further study details as provided by Pontificia Universidad Catolica de Chile:

Primary Outcome Measures:
  • AUDIT score [ Time Frame: 6 months post brief intervention ]

Estimated Enrollment: 262
Study Start Date: December 2015
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brief intervention
AUDIT brief intervention
Behavioral: AUDIT brief intervention
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.
Other: Pamphlet on alcohol use
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.
Sham Comparator: Control group
Pamphlet on alcohol use
Other: Pamphlet on alcohol use
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642757


Contacts
Contact: Andrea Rioseco, MD (56-2) 2354 8535 andreariosecoc@gmail.com
Contact: Nicolas Barticevic, MD (56-2) 2354 8535 nbarticevic@med.puc.cl

Locations
Chile
CESFAM San Alberto Hurtado Recruiting
Santiago, Puente Alto, Chile, 8181297
Contact: Aracelly Godoy, Med.SW       aracelly88@gmail.com   
CESFAM Madre Teresa de Calcuta Recruiting
Santiago, Puente Alto, Chile
Contact: Aracelly Godoy, Med.SW       aracelly88@gmail.com   
CESFAM Barros Luco Recruiting
Santiago, San Miguel, Chile
Contact: Aracelly Godoy, Med.SW       aracelly88@gmail.com   
CESFAM Recreo Recruiting
Santiago, San Miguel, Chile
Contact: Aracelly Godoy, Med.SW       aracelly88@gmail.com   
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
Principal Investigator: Nicolas Barticevic, MD Instructor Professor
  More Information

Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT02642757     History of Changes
Other Study ID Numbers: 14-214
SM14I0033 ( Other Grant/Funding Number: FONIS Chile )
First Submitted: December 28, 2015
First Posted: December 30, 2015
Last Update Posted: October 12, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Pontificia Universidad Catolica de Chile:
alcohol drinking
hazardous alcohol use
risky alcohol consumption
heavy alcohol consumption

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs