- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02491866
Computerized Adaptative Testing of Self-perceived Quality of Care in Psychiatry (QDSPsyCAT)
August 8, 2017 updated by: Assistance Publique Hopitaux De Marseille
Development and Implementation of a Computerized Adaptative Testing (CAT) of Self-perceived Quality of Care in Psychiatry
Objectives
- to develop and validate a Computerized Adaptative Testing (CAT) of self-perceived quality of care in Psychiatry.
- to analyze the implementation of this new measure in clinical practice : qualitative analysis of the relationship patient/professional.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Prospective and multicentric study
Development and validation of the CAT. 4 steps :
- Elaboration of a pool of items, based on literature review and interview with patients.
- Selection of the most relevant items based on a qualitative approach using cognitive interview with patients.
- Calibration of the item bank : the psychometric properties of the item bank will be based on classical test and item response theories and approaches, including the evaluation of unidimensionality, item response theory model fitting, and analyses of differential item functioning.
- Metrological validation of the CAT.
- Analysis of the implementation of the CAT in clinical practice using interview with professionals and patients.
Study Type
Interventional
Enrollment (Anticipated)
1400
Phase
- Not Applicable
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
-
-
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Marseille, France, 13354
- Recruiting
- Hôpital de la conception Assistance Publique Hôpitaux de Marseille
-
Contact:
- Laurent BOYER
- Phone Number: 04 91 38 75 83
- Email: laurent.boyer@ap-hm.fr
-
-
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
19 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- diagnosis of schizophrenia, bipolar disorder or depression according DSM V
- criteria
- age over 18 years
- informed consent to participate
- French as the native language
Exclusion Criteria:
- diagnosis other than schizophrenia, bipolar disorder or depression according DSM V criteria
- decompensated organic disease, and mental retardation
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
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: psychiatric patients
patients with schizophrenia, bipolar disorder or depression according DSM V criteria
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of care
Time Frame: 19 months
|
computerized Adaptative Testing
|
19 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Fernandes S, Fond G, Zendjidjian X, Michel P, Lancon C, Berna F, Schurhoff F, Aouizerate B, Henry C, Etain B, Samalin L, Leboyer M, Misdrahi D, Llorca PM, Coldefy M, Auquier P, Baumstarck K, Boyer L. A conceptual framework to develop a patient-reported experience measure of the quality of mental health care: a qualitative study of the PREMIUM project in France. J Mark Access Health Policy. 2021 Feb 23;9(1):1885789. doi: 10.1080/20016689.2021.1885789.
- Fernandes S, Fond G, Zendjidjian XY, Baumstarck K, Lancon C, Berna F, Schurhoff F, Aouizerate B, Henry C, Etain B, Samalin L, Leboyer M, Llorca PM, Coldefy M, Auquier P, Boyer L; French PREMIUM Group. Measuring the Patient Experience of Mental Health Care: A Systematic and Critical Review of Patient-Reported Experience Measures. Patient Prefer Adherence. 2020 Nov 3;14:2147-2161. doi: 10.2147/PPA.S255264. eCollection 2020.
- Fernandes S, Fond G, Zendjidjian X, Michel P, Baumstarck K, Lancon C, Berna F, Schurhoff F, Aouizerate B, Henry C, Etain B, Samalin L, Leboyer M, Llorca PM, Coldefy M, Auquier P, Boyer L. The Patient-Reported Experience Measure for Improving qUality of care in Mental health (PREMIUM) project in France: study protocol for the development and implementation strategy. Patient Prefer Adherence. 2019 Jan 21;13:165-177. doi: 10.2147/PPA.S172100. eCollection 2019.
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 (Actual)
May 27, 2015
Primary Completion (Actual)
August 1, 2017
Study Completion (Anticipated)
October 1, 2018
Study Registration Dates
First Submitted
June 24, 2015
First Submitted That Met QC Criteria
July 2, 2015
First Posted (Estimate)
July 8, 2015
Study Record Updates
Last Update Posted (Actual)
August 9, 2017
Last Update Submitted That Met QC Criteria
August 8, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-22
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.