Study of Effectiveness of Adding the Health Promotion and Rehabilitation for Treatment for Alcohol and Drug Abusers

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of adding the Health Promotion activities and rehabilitation to the usual alcohol and drug interventions on the outcome for alcohol and drug abusers compared to the usual intervention alone.

Detailed Description
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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.

Official Title
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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

Conditions
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Alcoholism, Substance-Related Disorders, Smoking, Chronic Disease, Malnutrition

Intervention / Treatment
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* Behavioral: Health promotion activities


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: alcohol or drug dependency Exclusion Criteria: withdrawal of informed consent missing competence to give informed consent pregnant or nursing women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Health Promotion activities<br> | Behavioral: Health promotion activities<br>* Counselled activities on tobacco smoking secession, diet correlation and physical activities<br>* Other names: diet;|
| No Intervention: No Intervention<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from abuser to non-abuser |  | 6 weeks, 3, 6, 9, 12 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health status |  | 6 weeks, 3, 6, 9, 12 and 24 months | 
| Quality of life |  | 6 weeks, 3,6,9,12 and 24 months | 
| Harm reduction |  | 6 weeks, 3,6,9,12 and 24 months | 
| Cost-effectiveness |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drinking Behavior, Harm Reduction, Tobacco Use Cessation, Smoking Cessation, Rehabilitation, Health Promotion, Nutrition Therapy, Feeding Behavior, Exercise