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Completed

NCT Number: NCT01414907

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

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.

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Key information

Conditions

Alcoholism Alcohol-Related Disorders Behavior Behavior, Animal Chemically-Induced Disorders Chronic Disease Disease Attributes Drinking Behavior Feeding Behavior Harm Reduction Health Behavior Malnutrition Mental Disorders Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Smoking Smoking Cessation Substance-Related Disorders Tobacco Use Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Addiction Center Malmo, Psychiatry Skane, Skane University Hospital

Malmö, Skåne County, 20502, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • alcohol or drug dependency

Exclusion criteria

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

Treatment and study plan

Health promotion activities

Behavioral

Counselled activities on tobacco smoking secession, diet correlation and physical activities

Other names: smoking secession, physical activity, diet

Primary outcomes

  1. Change from abuser to non-abuser

    Time frame: 6 weeks, 3, 6, 9, 12 and 24 months

Secondary outcomes

  1. Health status

    Time frame: 6 weeks, 3, 6, 9, 12 and 24 months

  2. Quality of life

    Time frame: 6 weeks, 3,6,9,12 and 24 months

  3. Harm reduction

    Time frame: 6 weeks, 3,6,9,12 and 24 months

  4. Cost-effectiveness

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Skane University Hospital

Other

Collaborators

  • Copenhagen University Hospital, Denmark
  • Lund University
  • Swedish Council for Working Life and Social Research
  • The Swedish Council for Information on Alcohol and Other Drugs

Registry information

Official study 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

Acronym: VIP

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Aug 11, 2011
Registry last updated
Jun 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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