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

Rare Diseases Clinical Trial

— RaroDentAXE3  

Official title:

Oral Health Related Quality of Life of Patients With Rare Diseases Followed at Necker Hospital: a Qualitative Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05070988
• Other study ID #: APHP210890
• Secondary ID: 2021-A00429-32
• Status: Completed
• Start date: October 20, 2021
• Est. completion date: November 29, 2021

Study information

• Verified date: June 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 29, 2021
• Est. primary completion date: November 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rare Diseases

Intervention

Other:
• Semi-structured interview
Semi-structured interview with the investigating doctor of the study lasting 30 minutes to an hour

Locations

Country	Name	City	State
France	Hôpital Necker-Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Friedlander L, Berdal A, Cormier-Daire V, Lyonnet S, Garcelon N. Determinants of dental care use in patients with rare diseases: a qualitative exploration. BMC Oral Health. 2023 Jun 22;23(1):413. doi: 10.1186/s12903-023-03048-1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral health-related quality of life assessment	Qualitative method from a semi-structured interview.	Day 0
Secondary	Description of oral health care pathways	Description from the semi-structured interviews.	Day 0
Secondary	Inequalities in access to oral health care	Description of inequalities in access to oral health care. Description from the semi-structured interviews.	Day 0