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NCT01414907 Clinical Trial

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

Smoking Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01414907
Other study ID # VIP-LU-2011
Secondary ID
Status Completed
Phase N/A
First received August 9, 2011
Last updated June 4, 2017
Start date October 2010
Est. completion date September 2015

Study information
Verified date June 2017
Source Skane University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 214
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- alcohol or drug dependency

Exclusion Criteria:

- withdrawal of informed consent

- missing competence to give informed consent

- pregnant or nursing women

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Health promotion activities
Counselled activities on tobacco smoking secession, diet correlation and physical activities

Locations
Country Name City State
Sweden Addiction Center Malmo, Psychiatry Skane, Skane University Hospital Malmo Skane

Sponsors (5)
Lead Sponsor Collaborator
Skane University Hospital Copenhagen University Hospital, Denmark, Lund University, Swedish Council for Working Life and Social Research, The Swedish Council for Information on Alcohol and Other Drugs

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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

Outcome
Type Measure Description Time frame Safety issue
Primary Change from abuser to non-abuser 6 weeks, 3, 6, 9, 12 and 24 months
Secondary Health status 6 weeks, 3, 6, 9, 12 and 24 months
Secondary Quality of life 6 weeks, 3,6,9,12 and 24 months
Secondary Harm reduction 6 weeks, 3,6,9,12 and 24 months
Secondary Cost-effectiveness 24 months
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