Clinical trial NCT05249322: Study of Satisfaction of Patients and Care Providers for an Alternate Follow-up With In-hospital Consults and Tele-consult for Patients With Cystic Fibrosis
Official title: FollowMuco : Study of Satisfaction of Patients and Care Providers for an Alternate Follow-up With In-hospital Consults and Tele-consult for Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cystic Fibrosis
Keywords: tele-medicine
cystic fibrosis
alternate follow-up
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The pandemic forced us to develop home follow-up for patients with chronical diseases . In the same time, the new era of treatment for cystic fibrosis considerably improves the health of patients with this pathology.

This study aims to assess the satisfaction of patients and care providers for an alternated follow-up between tele-consults and in-hospital consults during one year for patients with cystic fibrosis treated by Kaftrio® since at least one year and stable.


Eligibility criteria: Inclusion Criteria:

* patients with cystic fibrosis
* Patients treated with Kaftrio® since one year
* autonomous patients
* patients without cognitive disorders
* Patients voluntary for this follow up
* patients with two tele-communication tools
* patients with FEV1\>50%
* patients with less of 2 antibiotics cure per year

Exclusion Criteria:

* all transplanted patients
* Pregnant patients
* Particular follow up needed in-hospital consult
* Persons deprived of their liberty by a judicial or administrative decision
* Persons subject to psychiatric care
* Persons admitted to a health or social establishment for purposes other than research
* Persons not affiliated to a social security scheme or beneficiaries of a similar scheme

Primary outcomes:
measure: Change in Patients and care providers satisfaction after one year of alternated follow-up (hospital Consults and Tele-consult)
timeFrame: Measured at inclusion and after one year of follow up.
Secondary outcomes:
measure: Patients and care providers satisfaction for tele consultation
timeFrame: Measured after tele-consult (at 6 month M+6 and at 12 month M+12)
measure: Comparison between FEV1 measured at the department's respiratory functional exploration center and FEV1 measured with the Spirobank ® during the same in-hospital visit.
timeFrame: At inclusion, 6month and 12 month
measure: effect on Patients and care providers quality of life
timeFrame: Measured at inclusion and after one year
measure: effect on Patients FEV1 (Forced expiratory volume)
timeFrame: Measured at inclusion and after one year
measure: effect on Patients antibiotic cure number
timeFrame: Measured at inclusion and after one year
measure: effect on patient's weight
timeFrame: Measured at inclusion and after one year
measure: Effect on Patients call and mail to CF center
timeFrame: Measured at inclusion and after one year
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
affiliation: adult cystic fibrosis centre Lyon
name: Thomas VIDAL
role: PRINCIPAL_INVESTIGATOR
References: