Cystic Fibrosis Adherence Study (KINOBS)

July 26, 2021 updated by: Hospices Civils de Lyon

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

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

197

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

  • France
      • Pierre-Bénite, France
        • Centre de Référence de la Mucoviscidose Lyon à l'hôpital Lyon Sud

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cohort of adult patients with cystic fibrosis and follow-up at the Lyon Reference Center.

Description

Inclusion Criteria:

  • respiratory symptoms
  • subnormal respiratory function (FEV1 < 80%)
  • without lung transplant

Exclusion Criteria:

  • lung transplantation approach

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

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

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

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)

November 1, 2019

Primary Completion (Actual)

June 2, 2020

Study Completion (Actual)

June 2, 2020

Study Registration Dates

First Submitted

January 2, 2020

First Submitted That Met QC Criteria

January 2, 2020

First Posted (Actual)

January 6, 2020

Study Record Updates

Last Update Posted (Actual)

July 27, 2021

Last Update Submitted That Met QC Criteria

July 26, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL19_0410

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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