- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02642757
Alcohol Brief Counseling in Primary Care
Effectiveness of a Brief Intervention for Reducing the Alcohol Use in Risky Users Delivered by Paramedics in Primary Care
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Metropolitana
-
Santiago, Metropolitana, Chile
- CESFAM Juan Pablo II
-
-
Puente Alto
-
Santiago, Puente Alto, Chile, 8181297
- CESFAM San Alberto Hurtado
-
Santiago, Puente Alto, Chile
- CESFAM Madre Teresa de Calcuta
-
-
San Miguel
-
Santiago, San Miguel, Chile
- CESFAM Barros Luco
-
Santiago, San Miguel, Chile
- CESFAM Recreo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Brief intervention
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.
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUDIT score
Time Frame: 6 months post brief intervention
|
Total of questions 1 to 10 (minimum 0, maximum 40)
|
6 months post brief intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUDIT-C score
Time Frame: 6 months post brief intervention
|
Total of questions 1 to 3 (minimum 0, maximum 12)
|
6 months post brief intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nicolas Barticevic, MD, Instructor Professor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-214
- SM14I0033 (Other Grant/Funding Number: FONIS Chile)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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