Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cystic Fibrosis Adherence Study (KINOBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04217889
Recruitment Status : Recruiting
First Posted : January 6, 2020
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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

Condition or disease Intervention/treatment
Cystic Fibrosis Other: Questionnaire

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Adherence to Chest Physiotherapy in Patients With Cystic Fibrosis (CF) at the Adult CF Center in Lyon
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cohort of adult patients with cystic fibrosis and follow-up at the Lyon Reference Center.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • lung transplantation approach

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217889


Contacts
Layout table for location contacts
Contact: Thomas VIDAL 4-78-86-56-71 ext +33 Thomas.vidal@chu-lyon.fr

Locations
Layout table for location information
France
Centre de Référence de la Mucoviscidose Lyon à l'hôpital Lyon Sud Recruiting
Pierre-Bénite, France
Contact: Thomas VIDAL         
Sponsors and Collaborators
Hospices Civils de Lyon
Layout table for additonal information
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04217889    
Other Study ID Numbers: 69HCL19_0410
First Posted: January 6, 2020    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Cystic Fibrosis
Adherence to chest physiotherapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases