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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:
ClinicalTrials.gov Identifier:
NCT00670371
First Posted: May 1, 2008
Last Update Posted: November 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: April 29, 2008
First Posted: May 1, 2008
Last Update Posted: November 25, 2009
Last Verified: November 2009

Keywords provided by AstraZeneca:
Caregiver burden

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders