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Impact of Cognitive & Metacognitive Performance on Knowledge Learning When Conducting Therapeutic Education Programs (MetaCOGNITION)

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ClinicalTrials.gov Identifier: NCT04590300
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : January 25, 2022
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Charles Perrens, Bordeaux

Study Description
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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.

Condition or disease Intervention/treatment Phase
Schizophrenia Bipolar Disorder Other: QUESTIONNAIRES Not Applicable

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact Des Performances Cognitives et métacognitives Sur l'Apprentissage de Connaissances Lors de la réalisation de Programmes d'éducation thérapeutique
Actual Study Start Date : October 6, 2020
Estimated Primary Completion Date : April 6, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Schizophrenia

1 questionnaire at the beginning of the study, before FTE program

1 questionnaire at the end of FTE

 Other: QUESTIONNAIRES

1 questionnaire at the beginning of the study, before FTE program

1 questionnaire at the end of FTE
Bipolar disorder

1 questionnaire at the beginning of the study, before FTE program

1 questionnaire at the end of FTE

 Other: QUESTIONNAIRES

1 questionnaire at the beginning of the study, before FTE program

1 questionnaire at the end of FTE


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of cognitive impairments on knowledge acquired through a therapeutic education program with Montreal Cognitive Assessment (MoCA) [ Time Frame: 1 year ]
    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

  2. Evaluation of metacognitive impairments on knowledge acquired through a therapeutic education program with Subjective Scale To Investigate Cognition in Schizophrenia (SSTICS) [ Time Frame: 1 year ]
    assess the impact of possible metacognitive impairments on knowledge acquired through a therapeutic education program Minimum value 21


Secondary Outcome Measures :
  1. assess the impact of self esteem acquired through a therapeutic education program with Rosenberg scale [ Time Frame: 1 year ]
    assess the evolution in self-esteem following this program.

  2. assess the impact of level of anxiety, acquired through a therapeutic education program with State-Trait-Anxiety Inventory (Forme Y) (STAI-Y) questionnaire [ Time Frame: 1 year ]
    assess the evolution in level of anxiety following this program.

  3. assess the impact of depressive symptomatology acquired through a therapeutic education program with Center for Epidemiologic Studies-Depression (CES-D) scale [ Time Frame: 1 year ]
    assess the evolution in depressive symptoms following this program.

  4. assess the impact of literacy on knowledge acquired through a therapeutic education program with Rapid Estimate for Adult Literacy in Medicine (REALM-R) questionnaire [ Time Frame: 1 year ]
    assess the evolution in quality of life following this program.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04590300


Contacts
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Contact: Clelia QUILES, MD +335 56 56 35 85 cquiles@ch-perrens.fr
Contact: Helen SAVARIEAU +33556563556 hsavarieau@ch-perrens.fr

Locations
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France
Centre Hospitalier CHARLES PERRENS Recruiting
Bordeaux, Nouvelle Aquitaine, France, 33076
Contact: Clélia QUILES, MD    +33556563585    cquiles@ch-perrens.fr   
Contact: Helen SAVARIEAU    +33556563556    hsavarieau@ch-perrens.fr   
Principal Investigator: Clélia QUILES, MD         
Sponsors and Collaborators
Centre Hospitalier Charles Perrens, Bordeaux
Investigators
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Principal Investigator: Clelia QUILES, MD CH Charles Perrens
More Information
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Publications:
Flavell J.H. Metacognition and cognitive monitoring. A new area of cognitive-developmental inquiry. Am Psychol. 1979; 34(10):906-11

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Responsible Party: Centre Hospitalier Charles Perrens, Bordeaux
ClinicalTrials.gov Identifier: NCT04590300    
Other Study ID Numbers: 2020-A00980-39
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: January 25, 2022
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Bipolar Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders