NCT00670371

Brief Summary

The objective is to find determinants for the subjective and objective burden of informal caregivers to patients who are requiring continued antipsychotic treatment for functional psychoses among factors related to the patient, the health care and support provision system and the informal caregiver him/her-self.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

9 active sites

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

Study Start

First participant enrolled

March 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2008

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

November 25, 2009

Status Verified

November 1, 2009

First QC Date

April 29, 2008

Last Update Submit

November 24, 2009

Conditions

Functional PsychosesInformal Caregivers

Keywords

Caregiver burden

Study Arms (2)

1

Patients having the following diagnoses are eligible for inclusion into the study: schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, delusional disorder, affective psychosis with mood incongruent delusions, psychotic disorder not otherwise specified or patients being actively psychotic.

2

Closest relative(s) /informal caregiver(s)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Psychiatric patients and informal caregivers. Selected from outpatient wards

You may qualify if:

  • Provision of informed consent
  • Patients, male or female, aged 18 years or more, suffering or having suffered from a psychotic episode and being in need of continuous antipsychotic medication.
  • The respective patient must have at least one informal caregiver.
  • Subjects (patients and informal caregivers) must be able to read and write.

You may not qualify if:

  • Diagnosis of dementia and such cognitive impairment which makes self assessments even with assistance unreliable (patients and informal caregivers).
  • Involvement in the planning and conduct of the study (patients and informal caregivers).
  • Other concurrent medical condition interfering with ability to complete study (patients and informal caregivers).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Research site

Bromma, Sweden

Location

Research Site

Danderyd, Sweden

Location

Research Site

Falköping, Sweden

Location

Research Site

Huddinge, Sweden

Location

Research Site

Lidingö, Sweden

Location

Research Site

Ljungby, Sweden

Location

Research Site

Malmo, Sweden

Location

Research Site

Solna, Sweden

Location

Research Site

Stockholm, Sweden

Location

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Eva Dencker Vansvik

    AstraZeneca, MC, Sweden

    STUDY DIRECTOR

  • Lena Flyckt

    Danderyds Hospital, Stockholm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 29, 2008

First Posted

May 1, 2008

Study Start

March 1, 2008

Study Completion

November 1, 2009

Last Updated

November 25, 2009

Record last verified: 2009-11

Locations

SE(9)