NCT00750776

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2003

Longer than P75 for all trials

Geographic Reach
1 country

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2008

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

April 16, 2013

Status Verified

April 1, 2013

First QC Date

September 10, 2008

Last Update Submit

April 14, 2013

Conditions

Antipsychotic TreatmentQuality AssuranceMedical Treatment

Keywords

Quality assurancemedical treatmentPatient satisfaction

Outcome Measures

Primary Outcomes (1)

  • GAF 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 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

    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

    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

    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.

    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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • All patients where a physician has decided to treat the patient with antipsychotics.
  • All patients that are treated within the Danish health care system

You may not qualify if:

  • Patients that are treated in accordance with "Law concerning freedom deprivation and other compulsion in psychiatry
  • Patients that are in judicial measure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Research Site

Slagelse, Dianalund, Denmark

Location

Research Site

Bjerringbro, Denmark

Location

Research Site

Brørup, Denmark

Location

Research Site

Copenhagen, Denmark

Location

Research Site

Esbjerg, Denmark

Location

ResearcH Site

Holbæk, Denmark

Location

Research Site

Hviding, Denmark

Location

Research Site

Næstved, Denmark

Location

Research Site

Thyholm, Denmark

Location

Research Site

Varde, Denmark

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, senior consultant, DMSci

Study Record Dates

First Submitted

September 10, 2008

First Posted

September 11, 2008

Study Start

August 1, 2003

Study Completion

August 1, 2012

Last Updated

April 16, 2013

Record last verified: 2013-04

Locations

DK(10)