KvaliMed - a Quality Project With Focus on Patients in Antipsychotic Treatment
This study has been terminated.
(Due to lack of financial support)
Sponsor:
Psychiatric Centre Rigshospitalet
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Anders Fink-Jensen, MD, DMSci, Psychiatric Centre Rigshospitalet
ClinicalTrials.gov Identifier:
NCT00750776
First received: September 10, 2008
Last updated: April 14, 2013
Last verified: April 2013
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Purpose
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.
| Condition |
|---|
|
Antipsychotic Treatment Quality Assurance Medical Treatment |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | KvaliMed - a Quality Project With Focus on Patients in Antipsychotic Treatment |
Further study details as provided by Psychiatric Centre Rigshospitalet:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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. ]
| Estimated Enrollment: | 212 |
| Study Start Date: | August 2003 |
| Study Completion Date: | August 2012 |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
Criteria
Inclusion Criteria:
- All patients where a physician has decided to treat the patient with antipsychotics.
- All patients that are treated within the Danish health care system
Exclusion Criteria:
- Patients that are treated in accordance with "Law concerning freedom deprivation and other compulsion in psychiatry
- Patients that are in judicial measure
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00750776
Locations
| Denmark | |
| Research Site | |
| Slagelse, Dianalund, Denmark | |
| Research Site | |
| Bjerringbro, Denmark | |
| Research Site | |
| Brorup, Denmark | |
| Research Site | |
| Esbjerg, Denmark | |
| ResearcH Site | |
| Holbaek, Denmark | |
| Research Site | |
| Hviding, Denmark | |
| Research Site | |
| Kobenhavn, Denmark | |
| Research Site | |
| Naestved, Denmark | |
| Research Site | |
| Thyholm, Denmark | |
| Research Site | |
| Varde, Denmark | |
Sponsors and Collaborators
Psychiatric Centre Rigshospitalet
AstraZeneca
Investigators
| Principal Investigator: | Soren Blikenberg | Research Centre for Psychiatry Vordingborg |
| Principal Investigator: | Michael Maagensen | Children Psychiatry Holbaek |
| Principal Investigator: | Karin Byrsting | Odense University Hospital Odense C Psychiatric Hospital Slagelse |
| Principal Investigator: | Marianne Jacoby | Outpatient TreatmentCopenhagen K |
| Principal Investigator: | Peter Christoffersen | Psychiatric Hospital Slagelse |
More Information
No publications provided
| Responsible Party: | Anders Fink-Jensen, MD, DMSci, Professor, senior consultant, DMSci, Psychiatric Centre Rigshospitalet |
| ClinicalTrials.gov Identifier: | NCT00750776 History of Changes |
| Other Study ID Numbers: | NIS-NDK-DUM-2002/1 |
| Study First Received: | September 10, 2008 |
| Last Updated: | April 14, 2013 |
| Health Authority: | Denmark: Danish Dataprotection Agency |
Keywords provided by Psychiatric Centre Rigshospitalet:
|
Quality assurance medical treatment Patient satisfaction |
Additional relevant MeSH terms:
|
Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 19, 2013