Back to resultsThe Effect of a Interdisciplinary Alcohol Cessation Intervention
Primary Purpose
Alcohol Use Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
"Booster session"
Sponsored by
About this trial
This is an interventional prevention trial for Alcohol Use Disorders focused on measuring Harmful use, Hazardous use, Dependence
Eligibility Criteria
Inclusion Criteria:
- Admission with an alcohol related disorder
Exclusion Criteria:
- Lack of ability to give informed consent
Sites / Locations
- Stavanger University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Lifestyle counseling
Treatment as usual
Arm Description
Outcomes
Primary Outcome Measures
Alcohol Use Disorder Identification -C (AUDIT-C)
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
Grams og alcohol pr week.
Readmissions
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)
Continous variable
Quality of Life
SF 12
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01208571
Brief Title
The Effect of a Interdisciplinary Alcohol Cessation Intervention
Official Title
The Effect of an Interdisciplinary "Booster" Session in Primary Care Following Brief Intervention in Hospitals - a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Stavanger HF
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorders
Keywords
Harmful use, Hazardous use, Dependence
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle counseling
Arm Type
Experimental
Arm Title
Treatment as usual
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
"Booster session"
Intervention Description
Motivational interview
Primary Outcome Measure Information:
Title
Alcohol Use Disorder Identification -C (AUDIT-C)
Description
Alcohol Use Disorder Identification -C. Dicothomous outcome. More or less than four points for women and five points for men.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Timeline followback
Description
Grams og alcohol pr week.
Time Frame
6 months
Title
Readmissions
Description
Readmission to a hospital for an alcohol related and/or a non-alcohol related condition within six months after discharge.
Time Frame
6 months
Title
Readiness to Change Questionaire (RTCQ)
Description
Continous variable
Time Frame
6 months
Title
Quality of Life
Description
SF 12
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Admission with an alcohol related disorder
Exclusion Criteria:
Lack of ability to give informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Åse Cristiansen, RN
Phone
+47 05151
Email
asci@sus.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristian Oppedal, MD
Organizational Affiliation
Helse Stavanger HF
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sverre Nesvaag, Dr
Organizational Affiliation
Helse Stavanger HF
Official's Role
Study Director
Facility Information:
Facility Name
Stavanger University Hospital
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristian Oppdal, MD
Phone
+47 48124947
Email
kiop@sus.no
12. IPD Sharing Statement
Learn more about this trial
The Effect of a Interdisciplinary Alcohol Cessation Intervention
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