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

Not Applicable

Completed

• Conditions: Substance-Related Disorders; Chronic Disease; Malnutrition; Alcoholism; Smoking
• Interventions: Behavioral: Health promotion activities

• Registration Number: NCT01414907
• Lead Sponsor: Skane University Hospital

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:

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 Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-08-09
• Study First Submitted QC: 2011-08-10
• Study First Posted: 2011-08-11
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-04
• Last Update Posted: 2017-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

• alcohol or drug dependency

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health Promotion activities	Health promotion activities	-

Primary Outcome Measures

Name	Time	Method
Change from abuser to non-abuser	6 weeks, 3, 6, 9, 12 and 24 months

Secondary Outcome Measures

Name	Time	Method
Health status	6 weeks, 3, 6, 9, 12 and 24 months
Quality of life	6 weeks, 3,6,9,12 and 24 months
Harm reduction	6 weeks, 3,6,9,12 and 24 months
Cost-effectiveness	24 months

Trial Locations

Locations (1)

Addiction Center Malmo, Psychiatry Skane, Skane University Hospital; 🇸🇪 Malmo, Skane, Sweden