AlcoholismVIPNCT01414907
Study of Effectiveness of Adding the Health Promotion and Rehabilitation for Treatment for Alcohol and Drug Abusers
A study testing Health promotion activities in people with Alcoholism and Substance-Related Disorders, run by Skane University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholism, Substance-Related Disorders, Smoking
- What is being tested?
- Health promotion activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2010to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- alcohol or drug dependency
Who cannot join
- withdrawal of informed consent
- missing competence to give informed consent
- pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Addiction Center Malmo, Psychiatry Skane, Skane University Hospital
Malmö, Skåne County, 20502
About this study
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
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.
Read the 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.
- Conditions
- Alcoholism, Substance-Related Disorders, Smoking, Chronic Disease, Malnutrition
- Being tested
- Health promotion activities
- Keywords
- Drinking Behavior, Harm Reduction, Tobacco Use Cessation, Smoking Cessation, Rehabilitation, Health Promotion, Nutrition Therapy, Feeding Behavior, Exercise
- Medical subject headings
- Alcoholism, Substance-Related Disorders, Smoking, Chronic Disease, Malnutrition, Drinking Behavior, Harm Reduction, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health promotion activitiesBehavioural
Also called smoking secession, physical activity, diet
Counselled activities on tobacco smoking secession, diet correlation and physical activities
| Study group | Role | What they receive |
|---|---|---|
| Health Promotion activities | Active comparator | Not described Receives: Behavioral: Health promotion activities |
| No Intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from abuser to non-abuser
Measured: 6 weeks, 3, 6, 9, 12 and 24 months
Secondary outcomes (4)
Health status
Measured: 6 weeks, 3, 6, 9, 12 and 24 months
Quality of life
Measured: 6 weeks, 3,6,9,12 and 24 months
Harm reduction
Measured: 6 weeks, 3,6,9,12 and 24 months
Cost-effectiveness
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startOct 2010
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Hanne Tønnesen, Lund University
- Investigators
- Hanne Tønnesen, MD, PhD, Principal investigator, WHO-CC, Bispebjerg University Hopital, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414907
- Sponsor's protocol ID
- VIP-LU-2011
- Acronym
- VIP
- Status last verified
- Jun 2017
- First submitted
- 9 Aug 2011
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01414907
- Acronym / sponsor ID
- VIP / VIP-LU-2011
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- 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
- Study start
- Oct 2010 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 11 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Promotion activities | Active comparator | Behavioral: Health promotion activities |
| No Intervention | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- alcohol or drug dependency
Key exclusion criteria (3 listed)
- withdrawal of informed consent
- missing competence to give informed consent
- pregnant or nursing women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health promotion activitiesAlso: smoking secession, physical activity, dietCounselled activities on tobacco smoking secession, diet correlation and physical activities | Behavioural | Health Promotion activities |
Primary outcome
Change from abuser to non-abuser
Time frame: 6 weeks, 3, 6, 9, 12 and 24 months
4 secondary outcomes
Health status
Time frame: 6 weeks, 3, 6, 9, 12 and 24 months
Quality of life
Time frame: 6 weeks, 3,6,9,12 and 24 months
Harm reduction
Time frame: 6 weeks, 3,6,9,12 and 24 months
Cost-effectiveness
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- BackgroundTønnesen 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
- VIP projectLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanne Tønnesen, MD, PhD principal investigator
WHO-CC, Bispebjerg University Hopital, Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health promotion activities in people with Alcoholism and Substance-Related Disorders, run by Skane University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from abuser to non-abuser (time frame: 6 weeks, 3, 6, 9, 12 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01414907, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.