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

June 4, 2017 updated by: Hanne Tønnesen, Skane University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

214

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Skane
      • Malmo, Skane, Sweden, 20502
        • Addiction Center Malmo, Psychiatry Skane, Skane University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • alcohol or drug dependency

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No Intervention
Active Comparator: Health Promotion activities
Behavioral: Health promotion activities
Counselled activities on tobacco smoking secession, diet correlation and physical activities
Other Names:
  • physical activity
  • diet
  • smoking secession

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Skane University Hospital

Collaborators

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

Investigators

  • Principal Investigator: Hanne Tønnesen, MD, PhD, WHO-CC, Bispebjerg University Hopital, Copenhagen, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2010

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

August 9, 2011

First Submitted That Met QC Criteria

August 10, 2011

First Posted (Estimate)

August 11, 2011

Study Record Updates

Last Update Posted (Actual)

June 6, 2017

Last Update Submitted That Met QC Criteria

June 4, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIP-LU-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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