Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-01-02 @ 12:46 AM
Study NCT ID:
NCT02642757
Status:
COMPLETED
Last Update Posted:
2019-05-22
First Post:
2015-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alcohol Brief Counseling in Primary Care
Sponsor:
Pontificia Universidad Catolica de Chile
Organization:
Study Overview
Official Title:
Effectiveness of a Brief Intervention for Reducing the Alcohol Use in Risky Users Delivered by Paramedics in Primary Care
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| SM14I0033 | OTHER_GRANT | FONIS Chile | View |