Clinical trial NCT01414907: Study of Effectiveness of Adding the Health Promotion and Rehabilitation for Treatment for Alcohol and Drug Abusers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcoholism
Substance-Related Disorders
Smoking
Chronic Disease
Malnutrition
Keywords: Drinking Behavior
Harm Reduction
Tobacco Use Cessation
Smoking Cessation
Rehabilitation
Health Promotion
Nutrition Therapy
Feeding Behavior
Exercise
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
Collaborators: name: Swedish Council for Working Life and Social Research
name: The Swedish Council for Information on Alcohol and Other Drugs
name: Lund University
name: Copenhagen University Hospital, Denmark
First posted: 2011-08-11
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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:

1. To map the health status and estimate the potential improvement for 400 alcohol and drug abusers
2. To pilot test the VIP program
3. 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 criteria: Inclusion Criteria:

* alcohol or drug dependency

Exclusion Criteria:

* withdrawal of informed consent
* missing competence to give informed consent
* pregnant or nursing women

Primary outcomes:
measure: Change from abuser to non-abuser
timeFrame: 6 weeks, 3, 6, 9, 12 and 24 months
Secondary outcomes:
measure: Health status
timeFrame: 6 weeks, 3, 6, 9, 12 and 24 months
measure: Quality of life
timeFrame: 6 weeks, 3,6,9,12 and 24 months
measure: Harm reduction
timeFrame: 6 weeks, 3,6,9,12 and 24 months
measure: Cost-effectiveness
timeFrame: 24 months
Other outcomes:
Locations:
city: Malmo
country: Sweden
facility: Addiction Center Malmo, Psychiatry Skane, Skane University Hospital
state: Skane
Study officials:
affiliation: WHO-CC, Bispebjerg University Hopital, Copenhagen, Denmark
name: Hanne Tønnesen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tønnesen H, Hovhannisyan K, Ehrnström M, Skibelund D, Kovacs J, Thornqvist K, Skagert E. Co-morbidity in drug and alcohol addicts - a VIP project. 19th International Conference on Health Promotion Hospitals and Health Services, June 2011, Turku, Finland