Cystic Fibrosis Adherence Study

Cystic Fibrosis Clinical Trial

— KINOBS  

Official title:

Study of the Adherence to Chest Physiotherapy in Patients With Cystic Fibrosis (CF) at the Adult CF Center in Lyon

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04217889
• Other study ID #: 69HCL19_0410
• Status: Completed
• Start date: November 1, 2019
• Est. completion date: June 2, 2020

Study information

• Verified date: July 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: June 2, 2020
• Est. primary completion date: June 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• respiratory symptoms

• subnormal respiratory function (FEV1 < 80%)

• without lung transplant

Exclusion Criteria:

• lung transplantation approach

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• Questionnaire
Short questionnaire that can be completed during the usual consultation.

Locations

Country	Name	City	State
France	Centre de Référence de la Mucoviscidose Lyon à l'hôpital Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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