KvaliMed - a Quality Project With Focus on Patients in Antipsychotic Treatment (KvaliMed)

April 14, 2013 updated by: Anders Fink-Jensen, MD, DMSci, Psychiatric Centre Rigshospitalet
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 Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Anticipated)

212

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • 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
        • Research Site
    • Dianalund
      • Slagelse, Dianalund, Denmark
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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

Outcome Measure
Time Frame
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
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.
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
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Psychiatric Centre Rigshospitalet

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

September 10, 2008

First Submitted That Met QC Criteria

September 10, 2008

First Posted (Estimate)

September 11, 2008

Study Record Updates

Last Update Posted (Estimate)

April 16, 2013

Last Update Submitted That Met QC Criteria

April 14, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NIS-NDK-DUM-2002/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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