Fibrous Dysplasia Clinical Trial
— Df-LifeOfficial title:
Df-Life : Quality of Life in Patients With Fibrous Dysplasia
Verified date | March 2024 |
Source | Hospices Civils de Lyon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Fibrous dysplasia (FD) is a congenital skeletal disorder with multiple complications such as bone pain, fractures, deformities and nerve compression. Few quantitative studies have demonstrated its physical, mental and social negative impacts on patients but none have qualitatively evaluated their global quality of life. Our hypothesis is that a better knowledge of the quality of life of FD patients should allow to target the actions to be implemented to improve patients'care. The main objective of this qualitative research is therefore to investigate the quality of life of FD patients through 2 approaches: a qualitative study with focus groups interviews addressing several themes: self-image, psychological and emotional well-being, difficulties and adaptative strategies; and a quantitative study to measure the impact of FD on quality of life and on olfaction (sometimes affected by nerve compression due to the disease) using standardized questionnaires Short Form 36 (SF36) and Self-reported Mini Olfactory Questionnaire (SELF-MOQ).
Status | Completed |
Enrollment | 149 |
Est. completion date | May 2, 2023 |
Est. primary completion date | November 28, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Men and women - 18 years and more - with Fibrous dysplasia - Being followed in the rheumatology Department of the E. Herriot Hospital in Lyon. - Non-opposition to take part in the study - written consent to the audio recording of the discussions. Exclusion Criteria: - Legal incapacity or limited legal capacity - Psychiatric or neurological condition that severely impairs comprehension - Difficulty understanding spoken French - Patients with another pathology with a major impact on quality of life |
Country | Name | City | State |
---|---|---|---|
France | Edouard Herriot Hospital - rheumatology | Lyon |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | FD Qualitative study: notions on quality of life | quality of life concepts that will emerge during group interviews. | during group interview (90 minutes) | |
Primary | FD Quantitative study: scores of quality of life and olfaction impairment | quality of life measured with SF36 score. Patients will answer to 11 questions. Olfaction impairment measured with SELF-MOQ olfaction score. Patients will answer to 14 questions | during 30 minutes |
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