- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04217889
Cystic Fibrosis Adherence Study (KINOBS)
Study of the Adherence to Chest Physiotherapy in Patients With Cystic Fibrosis (CF) at the Adult CF Center in Lyon
This study aims to assess the role of some factors which can influence the chest physiotherapy adherence in adult with cystic fibrosis.
At first, we are going to try to consider the adherence of chest physiotherapy. Then, after dividing the patients into two groups - adherent or not adherent - we will attempt to identify the factors which can influence this adherence.
It consists in a short questionnaire that the patient will fill during usual visits.
The hypothesis is that the following factors can play a role in adherence of chest physiotherapy:
- Age
- Age of diagnostic
- Sex
- Fev1
- Number of antibiotic course
- Anxiety/depression
- Work time
- Socio-professional category
- Individual situation
- Physiotherapy with liberal physiotherapist and transport time
- Sport practice
- Family support
- Feeling of work time burden
- Feeling of physiotherapy efficiency
- Feeling of physiotherapy burden
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Pierre-Bénite, France
- Centre de Référence de la Mucoviscidose Lyon à l'hôpital Lyon Sud
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- respiratory symptoms
- subnormal respiratory function (FEV1 < 80%)
- without lung transplant
Exclusion Criteria:
- lung transplantation approach
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Adherent patient
This group is composed of adherent patients to the chest physiotherapy based on the number of chest physiotherapy session per week.
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Short questionnaire that can be completed during the usual consultation.
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Not-adherent patient
This group is composed of not-adherent patients to the chest physiotherapy based on the number of chest physiotherapy session per week.
|
Short questionnaire that can be completed during the usual consultation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantity of chest physiotherapy
Time Frame: 8 months
|
If the quantity of chest physiotherapy alone (do well) or/and with physiotherapist is above or egal at 3 per week, the patient is "adherent" If the quantity of chest physiotherapy is under 3 sessions per week, the patient is "not- adherent" Then we measure the proportion of each group for each secondary factors.
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8 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL19_0410
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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-
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