The Effect of a Interdisciplinary Alcohol Cessation Intervention

August 29, 2012 updated by: Helse Stavanger HF

The Effect of an Interdisciplinary "Booster" Session in Primary Care Following Brief Intervention in Hospitals - a Randomized Clinical Trial

The effect of alcohol interventions seems to be related to the intensity of the interventions. In this study the investigators will assess the effect of a interdisciplinary "booster session" in primary care, given to patients who were admitted to hospitals with alcohol related conditions, and who were given Brief Intervention before discharge. The booster session is based on a motivational interview.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The study is a randomized clinical trial, and aims to recruit 60 X 2 patients. Patients admitted to Stavanger University Hospital with an alcohol contributed condition, and who has been given a brief alcohol intervention may be recruited. Candidates for secondary healthcare related to alcohol misuse will be excluded. The interdisciplinary "booster" session will be given two weeks after discharge, and will be given in the facility of the primary care physician, facilitated by both the physician and an liaison alcohol nurse from Stavanger University Hospital. The intervention is based on motivational interview technique. The primary outcome will be assessed using the Alcohol Use Disorder Identification Test-C, six months after discharge. The outcome assessor will be blinded for the intervention. All outcomes will be collected by telephone interview.

The study aims to start recruiting candidates in October-November 2010, and will stoop recruiting in December 2012 at the latest.

The study was approved by the national ethical comite in August 2011. The results of the study wil be published in international referee based journals.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Stavanger, Norway, 4011
        • Recruiting
        • Stavanger University Hospital
        • Contact:
          • Kristian Oppdal, MD
          • Phone Number: +47 48124947
          • Email: kiop@sus.no

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Admission with an alcohol related disorder

Exclusion Criteria:

  • Lack of ability to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: Lifestyle counseling
Other: "Booster session"
Motivational interview
No Intervention: Treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol Use Disorder Identification -C (AUDIT-C)
Time Frame: 6 months
Alcohol Use Disorder Identification -C. Dicothomous outcome. More or less than four points for women and five points for men.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timeline followback
Time Frame: 6 months
Grams og alcohol pr week.
6 months
Readmissions
Time Frame: 6 months
Readmission to a hospital for an alcohol related and/or a non-alcohol related condition within six months after discharge.
6 months
Readiness to Change Questionaire (RTCQ)
Time Frame: 6 months
Continous variable
6 months
Quality of Life
Time Frame: 6 months
SF 12
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Stavanger HF

Investigators

  • Study Chair: Kristian Oppedal, MD, Helse Stavanger HF
  • Study Director: Sverre Nesvaag, Dr, Helse Stavanger HF

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

September 22, 2010

First Submitted That Met QC Criteria

September 23, 2010

First Posted (Estimate)

September 24, 2010

Study Record Updates

Last Update Posted (Estimate)

August 30, 2012

Last Update Submitted That Met QC Criteria

August 29, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-1883

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Alcohol Use Disorders

Clinical Trials on "Booster session"

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe