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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

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00670371
Collaborator
(none)
100
Enrollment
9
Locations
20
Duration (Months)
11.1
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated 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 :
    Mar 1, 2008
    Actual Study Completion Date :
    Nov 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    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)

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      Site City State Country Postal Code
      1 Research site Bromma Sweden
      2 Research Site Danderyd Sweden
      3 Research Site Falkoping Sweden
      4 Research Site Huddinge Sweden
      5 Research Site Lidingo Sweden
      6 Research Site Ljungby Sweden
      7 Research Site Malmo Sweden
      8 Research Site Solna Sweden
      9 Research Site Stockholm Sweden

      Sponsors and Collaborators

      • AstraZeneca

      Investigators

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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00670371
      Other Study ID Numbers:
      • NIS-NSE-DUM-2007/1
      First Posted:
      May 1, 2008
      Last Update Posted:
      Nov 25, 2009
      Last Verified:
      Nov 1, 2009
      Keywords provided by , ,
      Caregiver burden
      Additional relevant MeSH terms:
      Psychotic Disorders
      Mental Disorders

      Study Results

      No Results Posted as of Nov 25, 2009