Improving the Well-being of Caregivers of Cystic Fibrosis Patients During Physiotherapy Treatment (MucoZar)

April 30, 2024 updated by: Pole Sante Grace de Dieu
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The subjects recruited are parents (father, mother, dyads (father+mother) of children suffering from cystic fibrosis) who agree to answer the various questionnaires.

Description

Inclusion Criteria:

  • parents (father, mother, dyads (father+mother) of children suffering from cystic fibrosis) who agree to answer the various questionnaires.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Zarit Burden Interview
Time Frame: 1 year
The Zarit Burden Interview, a popular caregiver self-report measure used, contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always).
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pole Sante Grace de Dieu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

March 17, 2024

First Submitted That Met QC Criteria

March 17, 2024

First Posted (Actual)

March 25, 2024

Study Record Updates

Last Update Posted (Estimated)

May 2, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20240104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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