Oral Health Related Quality of Life of Patients with Rare Diseases: a Qualitative Approach

Completed

• Conditions: Rare Diseases
• Interventions: Other: Semi-structured interview

• Registration Number: NCT05070988
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The main objective of the study is to assess the oral health-related quality of life of patients with rare diseases and followed in the rare disease centers of expertise at Necker Hospital in Paris by semi-structured interviews.

Detailed Description

To date, few studies have used the qualitative method to analyze the oral health-related quality of life and the oral health care pathways of patients with rare diseases, all health sectors combined. The quantitative studies carried out using standardized questionnaires offer only a partial view of how patients feel, both children and adults.

The main objective of the study is to assess the oral health-related quality of life of patients with rare diseases and followed in the rare disease centers of expertise at Necker Hospital in Paris by means of a semi-structured interview.

Study Timeline

• Study First Submitted: 2021-09-27
• Study First Submitted QC: 2021-09-27
• Study First Posted: 2021-10-07
• Study Start: 2021-10-20
• Primary Completion: 2021-11-29
• Study Completion: 2021-11-29
• Status Verified: 2023-06
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Minor and adult patients with rare diseases aged of at least 6 years old and followed at the Necker Enfant Malades Hospital, Paris
• Patients with the 3 most frequent rare diseases of each rare disease Necker reference center participating in the study (10 centers : Chronic And Malformative Disorders Of The Esophagus / Inflammatory diseases of the bile ducts and autoimmune hepatitis / Constitutional Bone Diseases / Inherited Metabolic Diseases / Biliary Atresia And Genetic Cholestases / Vascular Diseases Of The Liver / Developmental Anomalies and Malformative Syndromes of Ile-De-France / Rare Causes Intellectual Disabilities / Complex congenital heart defects / Childhood cerebrovascular pathologies)
• Patients who consulted between 1.1.2017 and 1.1.2020 the relevant rare disease reference center at Necker hospital
• Patients seen at least once in the medical genetics department of Necker Hospital
• Information and non-opposition of adult patients / holders of parental authority of minor patients and minor patients to participate in the study

Exclusion Criteria

Patients who do not speak French

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rare diseases	Semi-structured interview	Children and adult patients with rare diseases and followed at the Necker Enfant Malades Hospital, Paris

Primary Outcome Measures

Name	Time	Method
Oral health-related quality of life assessment	Day 0	Qualitative method from a semi-structured interview.

Secondary Outcome Measures

Name	Time	Method
Description of oral health care pathways	Day 0	Description from the semi-structured interviews.
Inequalities in access to oral health care	Day 0	Description of inequalities in access to oral health care. Description from the semi-structured interviews.

Trial Locations

Locations (1)

Hôpital Necker-Enfants Malades; 🇫🇷 Paris, France