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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

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ClinicalTrials.gov Identifier: NCT00670371
Recruitment Status : Completed
First Posted : May 1, 2008
Last Update Posted : November 25, 2009
Sponsor:
Information provided by:
AstraZeneca

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.

Condition or disease
Functional Psychoses Informal Caregivers

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.

Study Type : Observational
Estimated Enrollment : 100 participants
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
Study Start Date : March 2008
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine


Group/Cohort
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)




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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).

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

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 Posted: May 1, 2008    Key Record Dates
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