Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-02-24 @ 2:06 PM
Study NCT ID:
NCT06327802
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving the Well-being of Caregivers of Cystic Fibrosis Patients During Physiotherapy Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-30', 'studyFirstSubmitDate': '2024-03-17', 'studyFirstSubmitQcDate': '2024-03-17', 'lastUpdatePostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Zarit Burden Interview', 'timeFrame': '1 year', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cystic Fibrosis', 'caregivers', 'burden'], 'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The subjects recruited are parents (father, mother, dyads (father+mother) of children suffering from cystic fibrosis) who agree to answer the various questionnaires.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* parents (father, mother, dyads (father+mother) of children suffering from cystic fibrosis) who agree to answer the various questionnaires.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06327802', 'acronym': 'MucoZar', 'briefTitle': 'Improving the Well-being of Caregivers of Cystic Fibrosis Patients During Physiotherapy Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Pole Sante Grace de Dieu'}, 'officialTitle': 'Improving the Well-being of Caregivers of Cystic Fibrosis Patients During Physiotherapy Treatment', 'orgStudyIdInfo': {'id': '20240104'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Participants will have to answer the socio-demographic questions (Age, weight, height, FEV1, FVC) and the Beck, Zarit, HAD, FAS CARERQOL-7D questionnaires'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume GALLIOU', 'role': 'CONTACT', 'email': 'guillaume.galliou@gmail.com', 'phone': '0231834802'}], 'facility': 'PSLA GDD', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pole Sante Grace de Dieu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}