NCT04217889

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 6, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2020

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

7 months

First QC Date

January 2, 2020

Last Update Submit

July 26, 2021

Conditions

Keywords

Cystic FibrosisAdherence to chest physiotherapy

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.

Other: Questionnaire

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

Interventions

Short questionnaire that can be completed during the usual consultation.

Adherent patientNot-adherent patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

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

Locations