Alcohol Use DisordersNCT01208571
The Effect of a Interdisciplinary Alcohol Cessation Intervention
A study testing "Booster session" in people with Alcohol Use Disorders, run by Helse Stavanger HF at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorders
- What is being tested?
- "Booster session"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission with an alcohol related disorder
Who cannot join
- Lack of ability to give informed consent
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Stavanger University Hospital
Stavanger, 4011
Kristian Oppdal, MD, +47 48124947, kiop@sus.no
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol Use Disorders
- Being tested
- "Booster session"
- Keywords
- Harmful use, Hazardous use, Dependence
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Booster session"Other
Motivational interview
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | Not described Receives: Other: "Booster session" |
| Treatment as usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
Timeline followback
Grams og alcohol pr week.
Measured: 6 months
Readmissions
Readmission to a hospital for an alcohol related and/or a non-alcohol related condition within six months after discharge.
Measured: 6 months
Readiness to Change Questionaire (RTCQ)
Continous variable
Measured: 6 months
Quality of Life
SF 12
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2010 (estimated)
- Study startApr 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kristian Oppedal, MD, Study chair, Helse Stavanger HFSverre Nesvaag, Dr, Study director, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208571
- Sponsor's protocol ID
- 2010-1883
- Status last verified
- Aug 2012
- First submitted
- 22 Sep 2010
- Last updated
- 30 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Interdisciplinary "Booster" Session in Primary Care Following Brief Intervention in Hospitals - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01208571
- Acronym / sponsor ID
- 2010-1883
- Conditions
- Alcohol Use Disorders
- Keywords
- Harmful use, Hazardous use, Dependence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Helse Stavanger HFOther government
- Study start
- Apr 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 24 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Other: "Booster session" |
| Treatment as usual | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Admission with an alcohol related disorder
Key exclusion criteria (1 listed)
- Lack of ability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Booster session"Motivational interview | Other | Lifestyle counseling |
Primary outcome
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.
4 secondary outcomes
Timeline followback
Time frame: 6 months
Readmissions
Time frame: 6 months
Readiness to Change Questionaire (RTCQ)
Time frame: 6 months
Quality of Life
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristian Oppedal, MD study chair
Helse Stavanger HF
Sverre Nesvaag, Dr study director
Helse Stavanger HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Booster session" in people with Alcohol Use Disorders, run by Helse Stavanger HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Åse Cristiansen, RN (+47 05151, asci@sus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Use Disorder Identification -C (AUDIT-C) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2012.