Study of Effectiveness of Adding the Health Promotion and Rehabilitation for Treatment for Alcohol and Drug Abusers (VIP)
|ClinicalTrials.gov Identifier: NCT01414907|
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : June 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Alcoholism Substance-Related Disorders Smoking Chronic Disease Malnutrition||Behavioral: Health promotion activities||Not Applicable|
Background: Alcohol and drug abuse are followed by tremendous physical, psychological and social problems as well as early death. Heavy smoking, poor nutrition, physical inactivity and chronic diseases (co-morbidity) are often part of these problems and illnesses.
There seems to be a large potential for a better outcome by including smoking cessation, physical training, diet and nutrition as well as co-morbidity in a multi-disciplinary setting - a potential not used yet. This Very Integrated Program (VIP) is inspired from the rehabilitation offered to patients with chronic diseases and surgical patients having a likewise unhealthy lifestyle and similar co-morbidity.
Aim: to evaluate the effect of adding the VIP program to the usual alcohol and drug intervention on the outcome for alcohol and drug abusers compared to the usual intervention alone.
The VIP project consists of 3 steps:
- To map the health status and estimate the potential improvement for 400 alcohol and drug abusers
- To pilot test the VIP program
- To evaluate it compared to the daily routines for 260 alcohol and drug abusers with a poor health status in a randomised controlled trial.
Main outcome: Change from abuser to non-abuser. Secondary outcomes are health status; quality of life, use of health services, time return to work (or similar activity level), harm reduction, and cost-effectiveness.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||214 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||VIP (Very Important Patient) Project on Alcohol and Drug Abusers - RCT of Efficacy of the Adding the Health Promotion and Rehabilitation for Treatment of Alcohol and Drug Abusers|
|Actual Study Start Date :||October 2010|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
|Active Comparator: Health Promotion activities||
Behavioral: Health promotion activities
Counselled activities on tobacco smoking secession, diet correlation and physical activities
|No Intervention: No Intervention|
- Change from abuser to non-abuser [ Time Frame: 6 weeks, 3, 6, 9, 12 and 24 months ]
- Health status [ Time Frame: 6 weeks, 3, 6, 9, 12 and 24 months ]
- Quality of life [ Time Frame: 6 weeks, 3,6,9,12 and 24 months ]
- Harm reduction [ Time Frame: 6 weeks, 3,6,9,12 and 24 months ]
- Cost-effectiveness [ Time Frame: 24 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01414907
|Addiction Center Malmo, Psychiatry Skane, Skane University Hospital|
|Malmo, Skane, Sweden, 20502|
|Principal Investigator:||Hanne Tønnesen, MD, PhD||WHO-CC, Bispebjerg University Hopital, Copenhagen, Denmark|