search
Back to results

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

Primary Purpose

Alcoholism, Substance-Related Disorders, Smoking

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Health promotion activities
Sponsored by
Skane University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring Drinking Behavior, Harm Reduction, Tobacco Use Cessation, Smoking Cessation, Rehabilitation, Health Promotion, Nutrition Therapy, Feeding Behavior, Exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • alcohol or drug dependency

Exclusion Criteria:

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

Sites / Locations

  • Addiction Center Malmo, Psychiatry Skane, Skane University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Health Promotion activities

No Intervention

Arm Description

Outcomes

Primary Outcome Measures

Change from abuser to non-abuser

Secondary Outcome Measures

Health status
Quality of life
Harm reduction
Cost-effectiveness

Full Information

First Posted
August 9, 2011
Last Updated
June 4, 2017
Sponsor
Skane University Hospital
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
search

1. Study Identification

Unique Protocol Identification Number
NCT01414907
Brief Title
Study of Effectiveness of Adding the Health Promotion and Rehabilitation for Treatment for Alcohol and Drug Abusers
Acronym
VIP
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

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
October 2010 (Actual)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Skane University Hospital
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health Promotion activities
Arm Type
Active Comparator
Arm Title
No Intervention
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Health promotion activities
Other Intervention Name(s)
smoking secession, physical activity, diet
Intervention Description
Counselled activities on tobacco smoking secession, diet correlation and physical activities
Primary Outcome Measure Information:
Title
Change from abuser to non-abuser
Time Frame
6 weeks, 3, 6, 9, 12 and 24 months
Secondary Outcome Measure Information:
Title
Health status
Time Frame
6 weeks, 3, 6, 9, 12 and 24 months
Title
Quality of life
Time Frame
6 weeks, 3,6,9,12 and 24 months
Title
Harm reduction
Time Frame
6 weeks, 3,6,9,12 and 24 months
Title
Cost-effectiveness
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: alcohol or drug dependency Exclusion Criteria: withdrawal of informed consent missing competence to give informed consent pregnant or nursing women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanne Tønnesen, MD, PhD
Organizational Affiliation
WHO-CC, Bispebjerg University Hopital, Copenhagen, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Addiction Center Malmo, Psychiatry Skane, Skane University Hospital
City
Malmo
State/Province
Skane
ZIP/Postal Code
20502
Country
Sweden

12. IPD Sharing Statement

Citations:
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
Results Reference
background
Links:
URL
http://www.med.lu.se/hvs/alkoholforskning/medarbetare/hanne_toennesen/vip_projektet
Description
VIP project

Learn more about this trial

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

We'll reach out to this number within 24 hrs