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Response Shift and Quality of Life in Patients Suffering From Schizophrenia and Their Caregivers (SCHIFT)

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Answering questionnaire
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Caregiver::

  • Person identified by the patient as the family member or friend who provided the most support or assistance,
  • Informed consent obtained
  • Being a native French speaker

Inclusion criteria patients:

  • Suffering of schizophrenia according DSM IV,
  • Informed consent obtained
  • Being a native French speaker

Exclusion Criteria:

  • Patient suffuring of demencia

Sites / Locations

  • Assistance Publique Hôpitaux de Marseille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient prsenting schizophrenia

Arm Description

Outcomes

Primary Outcome Measures

Numbers of response shift occuring in patients suffering from schizophrenia and in their caregivers

Secondary Outcome Measures

Full Information

First Posted
August 11, 2016
Last Updated
August 11, 2016
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02868307
Brief Title
Response Shift and Quality of Life in Patients Suffering From Schizophrenia and Their Caregivers
Acronym
SCHIFT
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Quality of life (QoL) measurements have become an important way to evaluate the treatments and care provided to patients with schizophrenia. Understanding determinants of QoL in schizophrenia is of importance for developing effective interventions that would improve patient functional and subjective well-being. A challenge in the interpretation of QoL measures, especially in longitudinal studies, is that QoL is self-reported by the patient and might be influenced by psychological phenomena such as adaptation to illness. An important mediator of this adaptation process is a "response shift" (RS), which involves changing internal standards, values and the conceptualization of QoL. RS can be divided into three phases 1) reconceptualization (i.e., a redefinition of QoL), 2) reprioritization (i.e., a change in the importance attributed to component domains constituting QoL) and 3) recalibration (i.e., a change in a patient's internal standards of measurements). Patients may change their frame of reference, rendering scores from different measurement occasions incomparable. An RS is a potential explanation when the QoL of an individual who has experienced a serious health event or chronic condition is similar to the QoL of a healthy individual. With an RS, the concept of QoL changes over time and cannot be compared longitudinally because of changes in internal standards, values, and/or concepts. True change may be over- or underestimated when a RS is present, leading to biased estimates of the magnitude of change.The objective is to examine whether a response shift, a change in the internal standards of a patient, occurs in patients suffering from schizophrenia and in their caregivers. This is a monocentric and propective design study, with inclusion of patients and caregivers on a 12-month period, and a follow up on a 12-month period. 100 patients with schizophrenia and 100 caregivers Test approach (Response shift (RS) (pre-test - then-test), unadjusted effect (post-test - pre-test), and adjusted effect (post-test - then-test scores)) will be completed with other statistical approaches such as confirmatory factorial analysis, multilevel models and CART method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient prsenting schizophrenia
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Answering questionnaire
Primary Outcome Measure Information:
Title
Numbers of response shift occuring in patients suffering from schizophrenia and in their caregivers
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Caregiver:: Person identified by the patient as the family member or friend who provided the most support or assistance, Informed consent obtained Being a native French speaker Inclusion criteria patients: Suffering of schizophrenia according DSM IV, Informed consent obtained Being a native French speaker Exclusion Criteria: Patient suffuring of demencia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urielle DESALBRES
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Laurent BOYER, MD
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

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Response Shift and Quality of Life in Patients Suffering From Schizophrenia and Their Caregivers

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