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Factors of Importance for the Subjective and Objective Burden of Informal Caregivers to Patients With Functional Psychoses - a Descriptive and Comparative Study

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00670371
First received: April 29, 2008
Last updated: November 24, 2009
Last verified: November 2009
History of Changes
  Purpose

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.


Condition
Functional Psychoses
Informal Caregivers

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Factors of Importance for the Subjective and Objective Burden of Informal Caregivers to Patients With Functional Psychoses - a Descriptive and Comparative Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Estimated Enrollment: 100
Study Start Date: March 2008
Study Completion Date: November 2009
Groups/Cohorts
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)

Detailed Description:

The study also comprises a descriptive part with the aim:

  • To describe clinical characteristics, symptoms, and functioning in the patient group.
  • To describe patient resource use in terms of support from the health care and social care sector.
  • To describe the socio-economic situation, the general and psychological health, and the coping ability of the informal caregivers.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Psychiatric patients and informal caregivers. Selected from outpatient wards

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00670371

Locations
Sweden
Research site
Bromma, Sweden
Research Site
Danderyd, Sweden
Research Site
Falkoping, Sweden
Research Site
Huddinge, Sweden
Research Site
Lidingo, Sweden
Research Site
Ljungby, Sweden
Research Site
Malmo, Sweden
Research Site
Solna, Sweden
Research Site
Stockholm, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Eva Dencker Vansvik AstraZeneca, MC, Sweden
Principal Investigator: Lena Flyckt Danderyds Hospital, Stockholm
  More Information

No publications provided

Responsible Party: Birgit Ekholm, MD, Medical Director Neuroscience, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00670371     History of Changes
Other Study ID Numbers: NIS-NSE-DUM-2007/1
Study First Received: April 29, 2008
Last Updated: November 24, 2009
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:
Caregiver burden

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 22, 2013