Antipsychotic TreatmentKvaliMedNCT00750776
KvaliMed - a Quality Project With Focus on Patients in Antipsychotic Treatment
An observational study of Antipsychotic Treatment and Quality Assurance, run by Psychiatric Centre Rigshospitalet at 10 sites in Denmark.
Trial summary
Rating and registration in KMS database of all patients in anti-psychotic treatment with 8 selected items from PANSS, GAF, 21 selected items from UKU, 3 selected items from TSQM. and measurement of compliance. Frequency of use of rating scales per participating health care professional. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Antipsychotic Treatment, Quality Assurance, Medical Treatment
- How many people
- 212 participants
- Where
- 10 sitesDenmark
- Study dates
- Aug 2003to Aug 2012
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients that are treatet with antipsycotic medicine - by a specialist in psychiatry - the patients can stay at the hospital or receive outpatient treatment
Who may be able to join
- All patients where a physician has decided to treat the patient with antipsychotics.
- All patients that are treated within the Danish health care system
Who cannot join
- Patients that are treated in accordance with "Law concerning freedom deprivation and other compulsion in psychiatry
- Patients that are in judicial measure
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Denmark10 sites
Research Site
Bjerringbro
Research Site
Brørup
Research Site
Copenhagen
Research Site
Esbjerg
ResearcH Site
Holbæk
Research Site
Hviding
Research Site
Næstved
Research Site
Slagelse, Dianalund
Research Site
Thyholm
Research Site
Varde
About this study
Rating and registration in KMS database of all patients in anti-psychotic treatment with 8 selected items from PANSS, GAF, 21 selected items from UKU, 3 selected items from TSQM. and measurement of compliance. Frequency of use of rating scales per participating health care professional.
- Keywords
- Quality assurance, medical treatment, Patient satisfaction
- Medical subject headings
- Patient Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
GAF score >= 30 or have an improvement on >= 5 points at the GAF scale
Measured: All measures are rated every ½ year at least.GAF: At least 85 % of the rated patients must have a score >= 30 or have an improvement on >= 5 points at the GAF scale
Secondary outcomes (4)
PANSS: Share af patients that have a score >= 3 on each an every of the following items P1, P2, P3, N1, N4, N6, G5, G9
Measured: PANSS: At least 70% of the patients have a score <= 3 on each an every of the following items P1, P2, P3, N1, N4, N6, G5, G9
UKU: Share of patients that have a score <=1 on the selected 21 items from the UKU scale
Measured: UKU: At least 75 % of the patients have a score on <=1 on the selected items UKU scale.At least 30 % of the patients are examined for metabolic syndrom.
Compliance: Share of patients have according to the specialists evaluation have taken their antipsychotic medicine according to prescription
Measured: Compliance: At least 75% of the patients have according to the specialists evaluation taken their antipsychotic medicine according to prescription
Patient satisfaction:Share of patients that scores in one of the to best categories i all selected 3 items in the TSQM scale.
Measured: Patient satisfaction:At least 65 % of the patients scores in one of the to best kategories in all the selected 3 items in the TSQM scale.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2008 (estimated)
- Study startAug 2003
- Study completionAug 2012
Why it stopped: Due to lack of financial support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antipsychotic TreatmentStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Psychiatric Centre Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Anders Fink-Jensen, MD, DMSci, Psychiatric Centre Rigshospitalet
- Investigators
- Soren Blikenberg, Principal investigator, Research Centre for Psychiatry VordingborgMichael Maagensen, Principal investigator, Children Psychiatry HolbaekKarin Byrsting, Principal investigator, Odense University Hospital Odense C Psychiatric Hospital SlagelseMarianne Jacoby, Principal investigator, Outpatient TreatmentCopenhagen KPeter Christoffersen, Principal investigator, Psychiatric Hospital Slagelse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750776
- Sponsor's protocol ID
- NIS-NDK-DUM-2002/1
- Acronym
- KvaliMed
- Status last verified
- Apr 2013
- First submitted
- 10 Sep 2008
- Last updated
- 16 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KvaliMed - a Quality Project With Focus on Patients in Antipsychotic Treatment
- ClinicalTrials.gov ID
- NCT00750776
- Acronym / sponsor ID
- KvaliMed / NIS-NDK-DUM-2002/1
- Keywords
- Quality assurance, medical treatment, Patient satisfaction
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to lack of financial support
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Psychiatric Centre RigshospitaletUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Aug 2003
- Study completion
- Aug 2012 (actual)
- First posted
- 11 Sep 2008 (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.
Rating and registration in KMS database of all patients in anti-psychotic treatment with 8 selected items from PANSS, GAF, 21 selected items from UKU, 3 selected items from TSQM. and measurement of compliance. Frequency of use of rating scales per participating health care professional.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients that are treatet with antipsycotic medicine - by a specialist in psychiatry - the patients can stay at the hospital or receive outpatient treatment
Key inclusion criteria (2 listed)
- All patients where a physician has decided to treat the patient with antipsychotics.
- All patients that are treated within the Danish health care system
Key exclusion criteria (2 listed)
- Patients that are treated in accordance with "Law concerning freedom deprivation and other compulsion in psychiatry
- Patients that are in judicial measure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
GAF score >= 30 or have an improvement on >= 5 points at the GAF scale
Time frame: All measures are rated every ½ year at least.GAF: At least 85 % of the rated patients must have a score >= 30 or have an improvement on >= 5 points at the GAF scale
4 secondary outcomes
PANSS: Share af patients that have a score >= 3 on each an every of the following items P1, P2, P3, N1, N4, N6, G5, G9
Time frame: PANSS: At least 70% of the patients have a score <= 3 on each an every of the following items P1, P2, P3, N1, N4, N6, G5, G9
UKU: Share of patients that have a score <=1 on the selected 21 items from the UKU scale
Time frame: UKU: At least 75 % of the patients have a score on <=1 on the selected items UKU scale.At least 30 % of the patients are examined for metabolic syndrom.
Compliance: Share of patients have according to the specialists evaluation have taken their antipsychotic medicine according to prescription
Time frame: Compliance: At least 75% of the patients have according to the specialists evaluation taken their antipsychotic medicine according to prescription
Patient satisfaction:Share of patients that scores in one of the to best categories i all selected 3 items in the TSQM scale.
Time frame: Patient satisfaction:At least 65 % of the patients scores in one of the to best kategories in all the selected 3 items in the TSQM scale.
Results and safety
The study was stopped early (reason given: Due to lack of financial support). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2013.
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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.
Soren Blikenberg principal investigator
Research Centre for Psychiatry Vordingborg
Michael Maagensen principal investigator
Children Psychiatry Holbaek
Karin Byrsting principal investigator
Odense University Hospital Odense C Psychiatric Hospital Slagelse
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antipsychotic Treatment and Quality Assurance, run by Psychiatric Centre Rigshospitalet at 10 sites 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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 16 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 was stopped early (reason given: Due to lack of financial support). Results are not available in the source record.
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?
GAF score >= 30 or have an improvement on >= 5 points at the GAF scale (time frame: All measures are rated every ½ year at least.GAF: At least 85 % of the rated patients must have a score >= 30 or have an improvement on >= 5 points at the GAF scale). 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 16 Apr 2013.