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

Impact Des Performances Cognitives et métacognitives Sur l'Apprentissage de Connaissances Lors de la réalisation de Programmes d'éducation thérapeutique

People with schizophrenia and bipolar disorder display alterations in cognition and metacognition. These alterations may have an impact on learning during therapeutic education programs.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Bipolar Disorder
• Intervention / Treatment: Other: QUESTIONNAIRES

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 Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nouvelle Aquitaine
    • Bordeaux, Nouvelle Aquitaine, France, 33076
      • Centre Hospitalier Charles Perrens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year
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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assess the impact of self esteem acquired through a therapeutic education program with Rosenberg scale	assess the evolution in self-esteem following this program.	1 year
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.	1 year
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.	1 year
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.	1 year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Charles Perrens, Bordeaux
• Investigators: Principal Investigator: Clelia QUILES, MD, CH Charles Perrens

Publications and helpful links

General Publications

• 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.
• 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.
• Flavell J.H. Metacognition and cognitive monitoring. A new area of cognitive-developmental inquiry. Am Psychol. 1979; 34(10):906-11

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2020
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Schizophrenia; Bipolar Disorder
• Other Study ID Numbers: 2020-A00980-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No