Impact of Cognitive & Metacognitive Performance on Knowledge Learning When Conducting Therapeutic Education Programs (MetaCOGNITION)
Primary Purpose
Schizophrenia, Bipolar Disorder
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
QUESTIONNAIRES
Sponsored by
About this trial
This is an interventional supportive care trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Consent to participate in the study,
- Suffering from a chronic condition for which an therapeutic patient education (TEP) program is proposed.
- Mastering the French language.
- Be a beneficiary of health insurance
Exclusion Criteria:
- Poor understanding of instructions that make it impossible to consent or assess
- Neurodegenerative disease
Sites / Locations
- Centre Hospitalier CHARLES PERRENSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Schizophrenia
Bipolar disorder
Arm Description
1 questionnaire at the beginning of the study, before FTE program 1 questionnaire at the end of FTE
1 questionnaire at the beginning of the study, before FTE program 1 questionnaire at the end of FTE
Outcomes
Primary Outcome Measures
Evaluation of cognitive impairments on knowledge acquired through a therapeutic education program with Montreal Cognitive Assessment (MoCA)
assess the impact of possible cognitive impairments on knowledge acquired through a therapeutic education program Minimum value = 0 & Maximum value = 30 Score < 26 is considered as abnormal
Evaluation of metacognitive impairments on knowledge acquired through a therapeutic education program with Subjective Scale To Investigate Cognition in Schizophrenia (SSTICS)
assess the impact of possible metacognitive impairments on knowledge acquired through a therapeutic education program Minimum value 21
Secondary Outcome Measures
assess the impact of self esteem acquired through a therapeutic education program with Rosenberg scale
assess the evolution in self-esteem following this program.
assess the impact of level of anxiety, acquired through a therapeutic education program with State-Trait-Anxiety Inventory (Forme Y) (STAI-Y) questionnaire
assess the evolution in level of anxiety following this program.
assess the impact of depressive symptomatology acquired through a therapeutic education program with Center for Epidemiologic Studies-Depression (CES-D) scale
assess the evolution in depressive symptoms following this program.
assess the impact of literacy on knowledge acquired through a therapeutic education program with Rapid Estimate for Adult Literacy in Medicine (REALM-R) questionnaire
assess the evolution in quality of life following this program.
Full Information
NCT ID
NCT04590300
First Posted
September 10, 2020
Last Updated
July 19, 2022
Sponsor
Centre Hospitalier Charles Perrens, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT04590300
Brief Title
Impact of Cognitive & Metacognitive Performance on Knowledge Learning When Conducting Therapeutic Education Programs
Acronym
MetaCOGNITION
Official Title
Impact Des Performances Cognitives et métacognitives Sur l'Apprentissage de Connaissances Lors de la réalisation de Programmes d'éducation thérapeutique
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 6, 2020 (Actual)
Primary Completion Date
August 6, 2022 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Charles Perrens, Bordeaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
People with schizophrenia and bipolar disorder display alterations in cognition and metacognition. These alterations may have an impact on learning during therapeutic education programs.
Detailed Description
Patient Therapeutic Education (FTE) is defined as a practice to help patients to acquire or maintain the skills needed to best manage their lives with a chronic disease. FTE includes organized awareness, information, learning and psychological and social assistance about the disease, prescribed treatments, various treatments offered, as well as information on organization of the global health system, and health behaviours. Performed by health professionals trained in this practice, FTE is intended to help patients and their close relatives and to understand their pathology, their treatments, collaborate with health care teams, and maintain or improve their quality of life. It aims to produce a complementary therapeutic effect of other health care interventions
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Bipolar Disorder
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Schizophrenia
Arm Type
Other
Arm Description
1 questionnaire at the beginning of the study, before FTE program
1 questionnaire at the end of FTE
Arm Title
Bipolar disorder
Arm Type
Other
Arm Description
1 questionnaire at the beginning of the study, before FTE program
1 questionnaire at the end of FTE
Intervention Type
Other
Intervention Name(s)
QUESTIONNAIRES
Intervention Description
1 questionnaire at the beginning of the study, before FTE program
1 questionnaire at the end of FTE
Primary Outcome Measure Information:
Title
Evaluation of cognitive impairments on knowledge acquired through a therapeutic education program with Montreal Cognitive Assessment (MoCA)
Description
assess the impact of possible cognitive impairments on knowledge acquired through a therapeutic education program Minimum value = 0 & Maximum value = 30 Score < 26 is considered as abnormal
Time Frame
1 year
Title
Evaluation of metacognitive impairments on knowledge acquired through a therapeutic education program with Subjective Scale To Investigate Cognition in Schizophrenia (SSTICS)
Description
assess the impact of possible metacognitive impairments on knowledge acquired through a therapeutic education program Minimum value 21
Time Frame
1 year
Secondary Outcome Measure Information:
Title
assess the impact of self esteem acquired through a therapeutic education program with Rosenberg scale
Description
assess the evolution in self-esteem following this program.
Time Frame
1 year
Title
assess the impact of level of anxiety, acquired through a therapeutic education program with State-Trait-Anxiety Inventory (Forme Y) (STAI-Y) questionnaire
Description
assess the evolution in level of anxiety following this program.
Time Frame
1 year
Title
assess the impact of depressive symptomatology acquired through a therapeutic education program with Center for Epidemiologic Studies-Depression (CES-D) scale
Description
assess the evolution in depressive symptoms following this program.
Time Frame
1 year
Title
assess the impact of literacy on knowledge acquired through a therapeutic education program with Rapid Estimate for Adult Literacy in Medicine (REALM-R) questionnaire
Description
assess the evolution in quality of life following this program.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Consent to participate in the study,
Suffering from a chronic condition for which an therapeutic patient education (TEP) program is proposed.
Mastering the French language.
Be a beneficiary of health insurance
Exclusion Criteria:
Poor understanding of instructions that make it impossible to consent or assess
Neurodegenerative disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clelia QUILES, MD
Phone
+335 56 56 35 85
Email
cquiles@ch-perrens.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Helen SAVARIEAU
Phone
+33556563556
Email
hsavarieau@ch-perrens.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clelia QUILES, MD
Organizational Affiliation
CH Charles Perrens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier CHARLES PERRENS
City
Bordeaux
State/Province
Nouvelle Aquitaine
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clélia QUILES, MD
Phone
+33556563585
Email
cquiles@ch-perrens.fr
First Name & Middle Initial & Last Name & Degree
Helen SAVARIEAU
Phone
+33556563556
Email
hsavarieau@ch-perrens.fr
First Name & Middle Initial & Last Name & Degree
Clélia QUILES, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21678337
Citation
Xia J, Merinder LB, Belgamwar MR. Psychoeducation for schizophrenia. Cochrane Database Syst Rev. 2011 Jun 15;2011(6):CD002831. doi: 10.1002/14651858.CD002831.pub2.
Results Reference
background
PubMed Identifier
29727072
Citation
Soo SA, Zhang ZW, Khong SJ, Low JEW, Thambyrajah VS, Alhabsyi SHBT, Chew QH, Sum MY, Sengupta S, Vieta E, McIntyre RS, Sim K. Randomized Controlled Trials of Psychoeducation Modalities in the Management of Bipolar Disorder: A Systematic Review. J Clin Psychiatry. 2018 May/Jun;79(3):17r11750. doi: 10.4088/JCP.17r11750.
Results Reference
background
Citation
Flavell J.H. Metacognition and cognitive monitoring. A new area of cognitive-developmental inquiry. Am Psychol. 1979; 34(10):906-11
Results Reference
background
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Impact of Cognitive & Metacognitive Performance on Knowledge Learning When Conducting Therapeutic Education Programs
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