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

Informal Caregivers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00670371
• Other study ID #: NIS-NSE-DUM-2007/1
• Status: Completed
• Phase: N/A
• First received: April 29, 2008
• Last updated: November 24, 2009
• Start date: March 2008
• Est. completion date: November 2009

Study information

• Verified date: November 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Functional Psychoses
• Informal Caregivers
• Mental Disorders
• Psychotic Disorders

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden,