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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Swedish Council for Working Life and Social Research
The Swedish Council for Information on Alcohol and Other Drugs
Lund University
Copenhagen University Hospital, Denmark
Information provided by (Responsible Party):
Hanne Tønnesen, Lund University
ClinicalTrials.gov Identifier:
NCT01414907
First received: August 9, 2011
Last updated: March 25, 2014
Last verified: March 2014
  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

Resource links provided by NLM:


Further study details as provided by Skane University Hospital:

Primary Outcome Measures:
  • Change from abuser to non-abuser [ Time Frame: 6 weeks, 3, 6, 9, 12 and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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: March 2015 (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:
  • smoking secession
  • physical activity
  • diet

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01414907

Locations
Sweden
Addiction Center Malmo, Psychiatry Skane, Skane University Hospital
Malmo, Skane, Sweden, 20502
Sponsors and Collaborators
Skane University Hospital
Swedish Council for Working Life and Social Research
The Swedish Council for Information on Alcohol and Other Drugs
Lund University
Copenhagen University Hospital, Denmark
Investigators
Principal Investigator: Hanne Tønnesen, MD, PhD WHO-CC, Bispebjerg University Hopital, Copenhagen, Denmark
  More Information

Additional Information:
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

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: March 25, 2014
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
Malnutrition
Nutrition Disorders
Substance-Related Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Disease Attributes
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014