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
FollowMuco
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
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2022
CompletedFirst Posted
Study publicly available on registry
February 21, 2022
CompletedStudy Start
First participant enrolled
March 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2024
CompletedSeptember 28, 2023
September 1, 2023
2 years
January 27, 2022
September 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Patients and care providers satisfaction after one year of alternated follow-up (hospital Consults and Tele-consult)
Satisfaction of patients and care providers for the follow-up by the Client-Satisfaction-Questionnaire (CSQ-8 for patients and CSQ-3 for care-provider). For the CSQ-8 the minimum value is 8 and the maximum value is 32. There is three levels: Low satisfaction (8-20), medium satisfaction (21-26) and high satisfaction (27-32) .
Measured at inclusion and after one year of follow up.
Secondary Outcomes (7)
Patients and care providers satisfaction for tele consultation
Measured after tele-consult (at 6 month M+6 and at 12 month M+12)
Comparison between FEV1 measured at the department's respiratory functional exploration center and FEV1 measured with the Spirobank ® during the same in-hospital visit.
At inclusion, 6month and 12 month
effect on Patients and care providers quality of life
Measured at inclusion and after one year
effect on Patients FEV1 (Forced expiratory volume)
Measured at inclusion and after one year
effect on Patients antibiotic cure number
Measured at inclusion and after one year
- +2 more secondary outcomes
Study Arms (1)
Follow-up alternating between face-to-face consultation and teleconsultation every three months
EXPERIMENTALPatients of this arm will be followed alternating between face-to-face consultation and teleconsultation respecting the recommended frequency (every three months) during 12 months (M+3:teleconsultation - M+6:in-hospital consultation - M+9:teleconsultation - M+12 : in-hospital consultation)
Interventions
The intervention will be an alternate follow-up every three months with: * A tele-consult: with paramedical consult (with assistance for home-spirometry) and medical consult for about 1h30 in total, make with a HCL platform for telemedicine. * An usual in-hospital consult of about 1h30 with paramedical and medical consult.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69 495, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas VIDAL
adult cystic fibrosis centre Lyon
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2022
First Posted
February 21, 2022
Study Start
March 31, 2022
Primary Completion
March 31, 2024
Study Completion
March 31, 2024
Last Updated
September 28, 2023
Record last verified: 2023-09