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
1 other identifier
observational
197
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2019
CompletedFirst Submitted
Initial submission to the registry
January 2, 2020
CompletedFirst Posted
Study publicly available on registry
January 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 2, 2020
CompletedJuly 27, 2021
July 1, 2021
7 months
January 2, 2020
July 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quantity of chest physiotherapy
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.
8 months
Study Arms (2)
Adherent patient
This group is composed of adherent patients to the chest physiotherapy based on the number of chest physiotherapy session per week.
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.
Interventions
Short questionnaire that can be completed during the usual consultation.
Eligibility Criteria
Cohort of adult patients with cystic fibrosis and follow-up at the Lyon Reference Center.
You may qualify if:
- respiratory symptoms
- subnormal respiratory function (FEV1 \< 80%)
- without lung transplant
You may not qualify if:
- lung transplantation approach
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre de Référence de la Mucoviscidose Lyon à l'hôpital Lyon Sud
Pierre-Bénite, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2020
First Posted
January 6, 2020
Study Start
November 1, 2019
Primary Completion
June 2, 2020
Study Completion
June 2, 2020
Last Updated
July 27, 2021
Record last verified: 2021-07