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OpenTrials
Completed

NCT Number: NCT04590300

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier CHARLES PERRENS

Bordeaux, New Aquitaine, 33076, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

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

1 questionnaire at the end of FTE

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Charles Perrens, Bordeaux

Other Gov

Registry information

Official study title

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

Acronym: MetaCOGNITION

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 19, 2020
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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