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

Medical Treatment Clinical Trial

— KvaliMed  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00750776
• Other study ID #: NIS-NDK-DUM-2002/1
• Status: Terminated
• Phase: N/A
• First received: September 10, 2008
• Last updated: April 14, 2013
• Start date: August 2003
• Est. completion date: August 2012

Study information

• Verified date: April 2013
• Source: Psychiatric Centre Rigshospitalet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 212
• Est. completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Antipsychotic Treatment
• Medical Treatment
• Quality Assurance

Locations

Country	Name	City	State
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	Slagelse	Dianalund
Denmark	Research Site	Thyholm
Denmark	Research Site	Varde

Sponsors (2)

Lead Sponsor	Collaborator
Psychiatric Centre Rigshospitalet	AstraZeneca

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	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
Secondary	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.