Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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21 November 2022 |
Main ID: |
NCT03047577 |
Date of registration:
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07/02/2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Brief Intervention for ICU Patients With Alcohol Use Disorders
ICU-BI |
Scientific title:
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Brief Intervention for ICU Patients With Alcohol Use Disorders- a Randomized Controlled Trial |
Date of first enrolment:
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March 30, 2017 |
Target sample size:
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237 |
Recruitment status: |
Terminated |
URL:
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https://clinicaltrials.gov/show/NCT03047577 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Finland
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- AUDIT-C score >5 (women) and >6 (men)
- Non-elective admission to the ICU
Exclusion Criteria:
- Terminal illness (expected to survive less than 6 months), palliative care
- Diagnosed severe mental illness (psychos, severe depression, bipolar disorder,
personality disorder)
- Cognitive disability
- Diagnosed dementia
- Impaired level of consciousness at discharge from the ICU (expected to remain
unchanged >2 days
- Other substance abuse (excluding cigarette smoking)
- Ongoing treatment for alcohol dependency
- Insufficient language skills (finnish/swedish)
- Expected difficulty in getting contacted by mail or telephone (no permanent address or
telephone in use)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Alcohol Use Disorder
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Critically Ill
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Intervention(s)
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Behavioral: Brief intervention
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Primary Outcome(s)
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Reported total amount of alcohol consumed during preceding week
[Time Frame: 6 months after study enrollment]
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Reported total amount of alcohol consumed during preceding week
[Time Frame: 12 months after study enrollment]
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Secondary Outcome(s)
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Quality of life
[Time Frame: One year after study enrollment]
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Change in AUDIT score
[Time Frame: 12 months after study enrollment]
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Change in AUDIT score
[Time Frame: 6 months after study enrollment]
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Mortality
[Time Frame: One year after study enrollment]
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Secondary ID(s)
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TYH2017105
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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