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

November 24, 2009 updated by: AstraZeneca
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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • 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
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Psychiatric patients and informal caregivers. Selected from outpatient wards

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Eva Dencker Vansvik, AstraZeneca, MC, Sweden
  • Principal Investigator: Lena Flyckt, Danderyds Hospital, Stockholm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion

December 6, 2022

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

April 29, 2008

First Submitted That Met QC Criteria

April 29, 2008

First Posted (Estimate)

May 1, 2008

Study Record Updates

Last Update Posted (Estimate)

November 25, 2009

Last Update Submitted That Met QC Criteria

November 24, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-NSE-DUM-2007/1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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