Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00400010
Status:
COMPLETED
Last Update Posted:
2014-04-02
First Post:
2006-11-14
Brief Title:
Alcohol Expert System Intervention for Problematic Alcohol Use
Sponsor:
University of Luebeck
Organization:
University of Luebeck
Study Overview
Official Title:
Randomized Controlled Trial of a Expert System for Patients With At-risk Drinking Alcohol Abuse and Alcohol Dependence in General Hospital
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In a randomized controlled trial patients recruited in a general hospital and fulfilling criteria for alcohol dependence alcohol abuse or at-risk drinking will be randomly allocated to two conditions1 Transtheoretical Model TTM-based expert system group patients receive an individualized feedback on drinking norms health-related risks and core constructs of the TTM augmented by a TTM-based manual 2 Control groupreceiving a booklet on health behavior
Outcome assessment will be conducted after 12 months The hypothesis is that individualized feedback leads to greater reduction in alcohol consumption and elevated readiness to change at follow-up
Outcome assessment will be conducted after 12 months The hypothesis is that individualized feedback leads to greater reduction in alcohol consumption and elevated readiness to change at follow-up
Detailed Description:
Background A promising approach in secondary prevention of problem drinking is to provide brief interventions in medical settings However brief interventions have not become implemented in general practices GPs due to insufficient role security and therapeutic commitment of physicians Computerized expert systems can provide very cost-effective means of intervention and have been effective in the field of smoking cessation However in the alcohol field research on this issue is scarce
Objectives Comparing an expert system based on the Transtheoretical Model of behavior change for patients with at-risk drinking alcohol abuse or alcohol dependence to a control condition Methods About 2500 screenings among consecutive general hospital patients aged 18 to 64 will be conducted Subjects fulfilling inclusion criteria severe alcohol dependence excluded will be randomly assigned to one of two conditions with 150 patients each 1 In the TTM-based expert system group patients receive an individualized feedback on drinking norms health-related risks and core constructs of the TTM augmented by a TTM-based manual 2 In the control group participants receive a booklet on health behavior Outcome assessment will be conducted after 12 months Outcome variables are alcohol consumption stages of change progress and utilization of formal help Expected impact Findings are expected to provide evidence for a computerized TTM based expert system to be used in primary care This would be the first international results confirming such an approach in the alcohol field If a TTM-based expert system would be effective this could significantly save resources and enhance secondary prevention Therefore data are of great public health interest Relationship to the objective of the collaboration As in the other studies empirical data on new proactive approaches to reach underserved populations in the addiction field will be provided The project will add knowledge on the economical use of interventions
Objectives Comparing an expert system based on the Transtheoretical Model of behavior change for patients with at-risk drinking alcohol abuse or alcohol dependence to a control condition Methods About 2500 screenings among consecutive general hospital patients aged 18 to 64 will be conducted Subjects fulfilling inclusion criteria severe alcohol dependence excluded will be randomly assigned to one of two conditions with 150 patients each 1 In the TTM-based expert system group patients receive an individualized feedback on drinking norms health-related risks and core constructs of the TTM augmented by a TTM-based manual 2 In the control group participants receive a booklet on health behavior Outcome assessment will be conducted after 12 months Outcome variables are alcohol consumption stages of change progress and utilization of formal help Expected impact Findings are expected to provide evidence for a computerized TTM based expert system to be used in primary care This would be the first international results confirming such an approach in the alcohol field If a TTM-based expert system would be effective this could significantly save resources and enhance secondary prevention Therefore data are of great public health interest Relationship to the objective of the collaboration As in the other studies empirical data on new proactive approaches to reach underserved populations in the addiction field will be provided The project will add knowledge on the economical use of interventions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None