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The Effect of a Interdisciplinary Alcohol Cessation Intervention

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by Helse Stavanger HF.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01208571
First Posted: September 24, 2010
Last Update Posted: August 30, 2012
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Helse Stavanger HF
  Purpose
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.

Condition Intervention
Alcohol Use Disorders Other: "Booster session"

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of an Interdisciplinary "Booster" Session in Primary Care Following Brief Intervention in Hospitals - a Randomized Clinical Trial

Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Timeline followback [ Time Frame: 6 months ]
    Grams og alcohol pr week.

  • 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.

  • Readiness to Change Questionaire (RTCQ) [ Time Frame: 6 months ]
    Continous variable

  • Quality of Life [ Time Frame: 6 months ]
    SF 12


Estimated Enrollment: 120
Study Start Date: April 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle counseling Other: "Booster session"
Motivational interview
No Intervention: Treatment as usual

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Admission with an alcohol related disorder

Exclusion Criteria:

  • Lack of ability to give informed consent
  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): NCT01208571


Contacts
Contact: Åse Cristiansen, RN +47 05151 asci@sus.no

Locations
Norway
Stavanger University Hospital Recruiting
Stavanger, Norway, 4011
Contact: Kristian Oppdal, MD    +47 48124947    kiop@sus.no   
Sponsors and Collaborators
Helse Stavanger HF
Investigators
Study Chair: Kristian Oppedal, MD Helse Stavanger HF
Study Director: Sverre Nesvaag, Dr Helse Stavanger HF
  More Information

Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01208571     History of Changes
Other Study ID Numbers: 2010-1883
First Submitted: September 22, 2010
First Posted: September 24, 2010
Last Update Posted: August 30, 2012
Last Verified: August 2012

Keywords provided by Helse Stavanger HF:
Harmful use
Hazardous use
Dependence