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

Schizophrenia Clinical Trial

— MetaCOGNITION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04590300
• Other study ID #: 2020-A00980-39
• Status: Completed
• Phase: N/A
• Start date: October 6, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Charles Perrens, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 31, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Schizophrenia

Intervention

Other:
• QUESTIONNAIRES
1 questionnaire at the beginning of the study, before FTE program 1 questionnaire at the end of FTE

Locations

Country	Name	City	State
France	Centre Hospitalier CHARLES PERRENS	Bordeaux	Nouvelle Aquitaine

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Charles Perrens, Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (3)

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

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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