NCT00541398

Brief Summary

The primary purpose of the study is to investigate whether an intensive educational intervention can reduce the use of antipsychotic polypharmacy. It is hypothesised that the use of antipsychotic polypharmacy is, in some degree, dependent on non-patient related factors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
222

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

November 2, 2009

Status Verified

October 1, 2009

Enrollment Period

1 year

First QC Date

October 9, 2007

Last Update Submit

October 30, 2009

Conditions

Schizophrenia

Keywords

Antipsychotic polypharmacySchizophreniaImplementation of clinical guidelines

Outcome Measures

Primary Outcomes (1)

  • Prevalence of antipsychotic polypharmacy

    1 year

Secondary Outcomes (1)

  • Questionnaire assessment of non-patient related factors. Medical records data. Cost-effectiveness analysis.

    1 year

Study Arms (2)

A

EXPERIMENTAL
Behavioral: Implementation of guideline

B

NO INTERVENTION

Interventions

Implementation of guidelineBEHAVIORAL

Outreach visits with interactive education for health staff

A

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The intervention is not aimed directly to the patients but their health care providers.
  • Patients with schizophrenia (F2\* diagnosis according to ICD-10) taking antipsychotic medication and their health care providers in the specified areas will enter the study:
  • The patients will enter with data from their medical record, register data and a few exploring interviews while the health staff will enter with their questionnaire data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CNSR

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Birte Glenthøj, Professor

    University of Copenhagen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 9, 2007

First Posted

October 10, 2007

Study Start

January 1, 2008

Primary Completion

January 1, 2009

Study Completion

October 1, 2009

Last Updated

November 2, 2009

Record last verified: 2009-10

Locations

DK(1)