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

NCT02868307 | Unknown

• 2 other identifiers: 2012-092012-A00343-40
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

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

  12 months

Study Arms (1)

Patient prsenting schizophrenia

EXPERIMENTAL

Behavioral: Answering questionnaire

Interventions

Answering questionnaire BEHAVIORAL

Patient prsenting schizophrenia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patient suffuring of demencia

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Urielle DESALBRES

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

• Laurent BOYER, MD

  Assistance Publique Hôpitaux de Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 16, 2016
• Study Start: July 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2017
• Last Updated: August 16, 2016

Record last verified: 2016-08

Locations

FR (1)