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OpenTrials
Completed

NCT Number: NCT02642757

Alcohol Brief Counseling in Primary Care

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CESFAM Madre Teresa de Calcuta, Santiago, Puente Alto, Chile

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AUDIT brief intervention

Behavioral

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.

Pamphlet on alcohol use

Other

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 outcomes

  1. AUDIT score

    Time frame: 6 months post brief intervention

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

Secondary outcomes

  1. AUDIT-C score

    Time frame: 6 months post brief intervention

    Total of questions 1 to 3 (minimum 0, maximum 12)

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Registry information

Official study title

Effectiveness of a Brief Intervention for Reducing the Alcohol Use in Risky Users Delivered by Paramedics in Primary Care

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 30, 2015
Registry last updated
May 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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