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

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

MedlinePlus related topics:

Caregivers Psychotic Disorders

U.S. FDA Resources

Study Type:	Observational
Study Design:	Other, 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

Further study details as provided by AstraZeneca:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	March 2008
Estimated Study Completion Date:	May 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

Contacts


Contact: AstraZenec Sweden Clinical Study Information	+46 8 553 260 00

Locations


Sweden
	Research Site	Recruiting
	LIDINGO, Sweden
	Research Site	Recruiting
	FALKOPING, Sweden
	Research Site	Recruiting
	LJUNGBY, Sweden
	Research Site	Recruiting
	Solna, Sweden
	Research Site	Recruiting
	MALMO, Sweden
	Research Site	Recruiting
	Göteborg, Sweden
	Research Site	Recruiting
	STOCKHOLM, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	Birgit Ekholm	AstraZeneca, MC, Sweden

Principal Investigator:	Lena Flyckt	Danderyds Hospital, Stockholm

More Information

Responsible Party:	AstraZeneca Pharmaceuticals ( Birgit Ekholm, MD, Medical Director Neuroscience )
Study ID Numbers:	NIS-NSE-DUM-2007/1
First Received:	April 29, 2008
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00670371
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:

Caregiver burden

Study placed in the following topic categories:

Schizophrenia

Mental Disorders

Psychotic Disorders

Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00670371