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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01208571
Other study ID # 2010-1883
Secondary ID
Status Recruiting
Phase N/A
First received September 22, 2010
Last updated August 29, 2012
Start date April 2011
Est. completion date December 2012

Study information

Verified date August 2012
Source Helse Stavanger HF
Contact Åse Cristiansen, RN
Phone +47 05151
Email asci@sus.no
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Admission with an alcohol related disorder

Exclusion Criteria:

- Lack of ability to give informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
"Booster session"
Motivational interview

Locations

Country Name City State
Norway Stavanger University Hospital Stavanger

Sponsors (1)

Lead Sponsor Collaborator
Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months No
Secondary Timeline followback Grams og alcohol pr week. 6 months No
Secondary Readmissions Readmission to a hospital for an alcohol related and/or a non-alcohol related condition within six months after discharge. 6 months No
Secondary Readiness to Change Questionaire (RTCQ) Continous variable 6 months No
Secondary Quality of Life SF 12 6 months No
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