NCT03850145

Brief Summary

Educational programs are essential for cystic fibrosis patients who need to take several different drugs every day. Compliance is often klow in these patients, and clinicals and paramedics try to increase it, through educational programs. As for inhaled therapies, the CF center of Montpellier uses a video conference tool to educate patients. The program may involve either the physiotherapist or the doctor or both. Through the present study, the investigators would like to evaluate the current practice at the CF center of Montpellier and verify if patients feel that the physiotherapist could handle the program on his own, without the support of a physician.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 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

February 1, 2019

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

10 months

First QC Date

February 18, 2019

Last Update Submit

March 9, 2020

Conditions

Keywords

inhaled therapyphysiotherapisteducational program

Outcome Measures

Primary Outcomes (2)

  • acceptability of the therapeutic education program by videoconference

    acceptability of the therapeutic education program by videoconference with a satisfaction questionnaire

    1 day

  • need for the presence of the referring physician in relation to a session of therapeutic education carried out by the physiotherapist alone

    need for the presence of the referring physician in relation to a session of therapeutic education carried out by the physiotherapist alone with a satisfaction questionnaire

    1 day

Eligibility Criteria

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

CF patients consulting at the CF center of Montpellier (France)

You may qualify if:

  • CF patients
  • patient regularly assessed at the CF center of Montpellier
  • major patients
  • patients who recently enrolled a video conference educational program or who will soon be part of it

You may not qualify if:

  • patients not able to participate to a video conference educational program, due to lack of tools at their home

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Davide CAIMMI

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2019

First Posted

February 21, 2019

Study Start

February 1, 2019

Primary Completion

December 1, 2019

Study Completion

December 30, 2019

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations