SchizophreniaNCT00497848
The Compliance Project Concerning People With Schizophrenia
A study testing motivational interviewing and The System-Orientated Intervention in people with Schizophrenia, run by Ministry of the Interior and Health, Denmark at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether individual and/ or system orientated interventions can help the problem of people with schizophrenia dropping out of their drug treatment Read more about this study
- Who is it for?
- Ages 23 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- motivational interviewing and The System-Orientated Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- May 2007to Jul 2009
- 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 23 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnoses of schizophrenia or schizoaffective psychosis
- 23 years or more
- Ethnic dane
- Living in the city of Odense.
Who cannot join
- not subject to legal action
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of psychiatry, Odense University Hospital
Odense, 5000 C
About this study
Official title: Individual Versus System Orientated Interventions in Handling Drug Related Problems in People With Schizophrenia
The purpose of this study is to determine whether individual and/ or system orientated interventions can help the problem of people with schizophrenia dropping out of their drug treatment
Read the detailed description
50% of people with schizophrenia do not take the prescribed medication leading to repeating relapses with loss of social and cognitive skills.
The individual intervention is based on "Motivational Interviewing" by Miller and "Concordance Strategies" by R. Gray.It is a cognitive behavioral therapy.
The system orientated intervention is building on principles from quality assurance and clinical risk managing. It seeks to improve the quality in the medical treatment by use of standards, monitoring, audit and root cause analysis,and thereby trying to find weak points in the system and subsequently improve the common practice.
- Conditions
- Schizophrenia
- Being tested
- motivational interviewing, The System-Orientated Intervention
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motivational interviewingBehavioural
Also called compliance therapy
An individual intervention building on the "Motivational Interviewing" by Miller and Rollnick. Several studies has proved effectiveness of this therapy form in improving drug compliance. Patients will be offered individual motivational therapy
The System-Orientated InterventionOther
Also called Clinical Risk Managing in Handling Compliance Problems
Principles in this intervention come from "Clinical Risk Managing" and quality assurance. It focuses on daily problems in drug handling, including dropping out of drug therapy, by looking at the system as a whole.Some cases, where patients dropped out of drug therapy will be carefully analysed in order to identify week points in the system, and subsequently alter the instructions for drug therapy, information, reminders and so on.
| Study group | Role | What they receive |
|---|---|---|
| motivational interviewing | Active comparator | Not described Receives: Behavioral: motivational interviewing |
| The System Orientated Intervention | Experimental | Not described Receives: Other: The System-Orientated Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
compliance assessed on a compliance-scale
Measured: follow-up time 6 months
Secondary outcomes (1)
assessment on a variety of scales concerning subjective well-being, GAF, PANSS-remission,CGI, side-effects.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2007 (estimated)
- Study startMay 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of the Interior and Health, Denmark
- Sponsor type
- Other government
- Investigators
- Bent Nielsen, Ph. D., Study director, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497848
- Sponsor's protocol ID
- MIH, Denmark
- Status last verified
- Jul 2007
- First submitted
- 6 Jul 2007
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Versus System Orientated Interventions in Handling Drug Related Problems in People With Schizophrenia
- ClinicalTrials.gov ID
- NCT00497848
- Acronym / sponsor ID
- MIH, Denmark
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ministry of the Interior and Health, DenmarkOther government
- Study start
- May 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 9 Jul 2007 (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 determine whether individual and/ or system orientated interventions can help the problem of people with schizophrenia dropping out of their drug treatment
Detailed description
50% of people with schizophrenia do not take the prescribed medication leading to repeating relapses with loss of social and cognitive skills.
The individual intervention is based on "Motivational Interviewing" by Miller and "Concordance Strategies" by R. Gray.It is a cognitive behavioral therapy.
The system orientated intervention is building on principles from quality assurance and clinical risk managing. It seeks to improve the quality in the medical treatment by use of standards, monitoring, audit and root cause analysis,and thereby trying to find weak points in the system and subsequently improve the common practice.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| motivational interviewing | Active comparator | Behavioral: motivational interviewing |
| The System Orientated Intervention | Experimental | Other: The System-Orientated Intervention |
Who may qualify
- Ages
- 23 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnoses of schizophrenia or schizoaffective psychosis
- 23 years or more
- Ethnic dane
- Living in the city of Odense.
Key exclusion criteria (1 listed)
- not subject to legal action
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 |
|---|---|---|
| motivational interviewingAlso: compliance therapyAn individual intervention building on the "Motivational Interviewing" by Miller and Rollnick. Several studies has proved effectiveness of this therapy form in improving drug compliance. Patients will be offered individual motivational therapy | Behavioural | motivational interviewing |
| The System-Orientated InterventionAlso: Clinical Risk Managing in Handling Compliance ProblemsPrinciples in this intervention come from "Clinical Risk Managing" and quality assurance. It focuses on daily problems in drug handling, including dropping out of drug therapy, by looking at the system as a whole.Some cases, where patients dropped out of drug therapy will be carefully analysed in order to identify week points in the system, and subsequently alter the instructions for drug therapy, information, reminders and so on. | Other | The System Orientated Intervention |
Primary outcome
compliance assessed on a compliance-scale
Time frame: follow-up time 6 months
1 secondary outcome
assessment on a variety of scales concerning subjective well-being, GAF, PANSS-remission,CGI, side-effects.
Time frame: 6 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 27 Jun 2011.
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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.
Bent Nielsen, Ph. D. study director
University of Southern 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 motivational interviewing and The System-Orientated Intervention in people with Schizophrenia, run by Ministry of the Interior and Health, Denmark at 1 site in Denmark.
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 4 inclusion and 1 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 27 Jun 2011. 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 Denmark. 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?
compliance assessed on a compliance-scale (time frame: follow-up time 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2011.