Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06327802 |
| Other study ID # |
20240104 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2024 |
| Est. completion date |
July 31, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Pole Sante Grace de Dieu |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The main objective of the study is to determine the impact of cystic fibrosis affecting a
child on the parents' quality of life, their possible anxiety and depressive symptoms, their
general fatigue and the feeling of burden in these caregivers.
Description:
Cystic fibrosis is the most common rare genetic disease in France, and in European countries
in general. According to current epidemiological data, 80,000 people worldwide are affected.
It represents a major public health issue, as it is a chronic disease that has a major impact
on the life expectancy of affected patients. Thanks to the latest medical advances, promising
treatments are now available, helping to improve patient survival rates to over 40-50 years.
Among existing treatments, respiratory and musculoskeletal physiotherapy are highly
recommended. It will play a key role throughout the life of a cystic fibrosis patient.
Patients with chronic respiratory diseases are at high risk of developing anxiety and
depressive symptoms. As the disease worsens, the patient becomes increasingly dependent,
leading to restrictions in participation and activities of daily living. As a result, the
presence of family and friends is of paramount importance in ensuring that sick children
adhere to treatment and take their medication. However, this workload on the part of a
parent, who has to make major changes to their lifestyle in order to adapt to their child's
treatment, can have a considerable impact on their well-being, and increase the risk of
anxiety/depression, even leading to burnout. Psychologists have studied the subject of
assessing quality of life in parents of children with cystic fibrosis. At present, knowing
that the quality of life of sufferers is as much affected as that of their caregivers,
questionnaires have been introduced to assess parents' quality of life, notably the
CarerQol-7D . The aim of this study would be to raise the issue of exhaustion among parents
of children with cystic fibrosis, and to consider how to reduce the impact of this heavy
mental burden on them. This would contribute to better therapeutic adherence and improved
treatment of children. To this end, questionnaires and interviews could be set up with
parents, with the aim of developing a relevant and optimal action strategy for their
children.
