Study of Effectiveness of Adding the Health Promotion and Rehabilitation for Treatment for Alcohol and Drug Abusers (VIP)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Alcoholism Substance-Related Disorders Smoking Chronic Disease Malnutrition |
Behavioral: Health promotion activities |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
- Change from abuser to non-abuser [ Time Frame: 6 weeks, 3, 6, 9, 12 and 24 months ] [ Designated as safety issue: No ]
- Health status [ Time Frame: 6 weeks, 3, 6, 9, 12 and 24 months ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 6 weeks, 3,6,9,12 and 24 months ] [ Designated as safety issue: No ]
- Harm reduction [ Time Frame: 6 weeks, 3,6,9,12 and 24 months ] [ Designated as safety issue: No ]
- Cost-effectiveness [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 260 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Health Promotion activities |
Behavioral: Health promotion activities
Counselled activities on tobacco smoking secession, diet correlation and physical activities
Other Names:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- alcohol or drug dependency
Exclusion Criteria:
- withdrawal of informed consent
- missing competence to give informed consent
- pregnant or lactating women
Contacts and Locations| Contact: Hanne Tønnesen, MD, PhD | 0046 (0) 40 33 29 85 | hanne.tonnesen@med.lu.se |
| Contact: Johanna Adami, MD, PhD | 0046 (0) 8 473 3076 | Johanna.Adami@ki.se |
| Sweden | |
| Addiction Center Malmo, Psychiatry Skane, Skane University Hospital | Recruiting |
| Malmo, Skane, Sweden, 20502 | |
| Principal Investigator: | Hanne Tønnesen, MD, PhD | WHO-CC, Bispebjerg University Hopital, Copenhagen, Denmark |
More Information
Additional Information:
Publications:
| Responsible Party: | Hanne Tønnesen, Professor, Lund University |
| ClinicalTrials.gov Identifier: | NCT01414907 History of Changes |
| Other Study ID Numbers: | VIP-LU-2011 |
| Study First Received: | August 9, 2011 |
| Last Updated: | October 9, 2011 |
| Health Authority: | Sweden: Institutional Review Board Sweden: Regional Ethical Review Board |
Keywords provided by Skane University Hospital:
|
Drinking Behavior Harm Reduction Tobacco Use Cessation Smoking Cessation Rehabilitation |
Health Promotion Nutrition Therapy Feeding Behavior Exercise |
Additional relevant MeSH terms:
|
Alcoholism Chronic Disease Smoking Malnutrition Substance-Related Disorders Alcohol-Related Disorders |
Mental Disorders Disease Attributes Pathologic Processes Habits Nutrition Disorders |
ClinicalTrials.gov processed this record on May 23, 2013