Clinical Trials Directory

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UnknownNCT05532956

Evaluation of the Impact of Tricuspid Regurgitation on Patients Lives. Exploration of Experience and Impact on a Daily Basis.

Status
Unknown
Phase
Study type
Observational
Enrollment
24 (estimated)
Sponsor
Gérond'if · Academic / Other
Sex
All
Age
6 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to objectively assess the impact of the pathology on the patient's life so as to best inform the choices of evaluators "the French National Authority for Health" (HAS) and decision makers "the Economics Committee for Health Products" (CEPS) through the expression of the patients' feelings themselves. For this, the study will assess the impact of severe tricuspid insufficiency and its symptoms on the quality of life of patients from a physical, psychological and social point of view.

Detailed description

Patients eligible for this study are selected by their cardiologist to participate in one of two interviews: * Individual semi-structured interview lasting 45 minutes to 1.5 hours conducted by a psychologist These interviews are recorded (voice recording by dictaphone). They address the experience of patients with different degrees of severity of the pathology (severe, massive or torrential regurgitation), questioning the different dimensions of the impact of tricuspid regurgitation on their life, as well as the hierarchy of consequences for their lives and their daily lives. * Collective interview lasting 1.5 hours to 2 hours which allows to consolidate the information obtained during the individual interviews in order to best assess the impact of the tricuspid regurgitation on the daily life and the patient experience.

Conditions

Timeline

Start date
2022-09-01
Primary completion
2022-09-01
Completion
2022-10-01
First posted
2022-09-08
Last updated
2022-09-08

Source: ClinicalTrials.gov record NCT05532956. Inclusion in this directory is not an endorsement.