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

Cystic Fibrosis Clinical Trial

— FollowMuco  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05249322
• Other study ID #: 69HCL21_1354
• Secondary ID: 2022-A00134-39
• Status: Recruiting
• Phase: N/A
• Start date: March 31, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: September 2023
• Source: Hospices Civils de Lyon
• Contact: Thomas VIDAL
• Phone: 478865671
• Email: Thomas.vidal[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• Follow-up alternating between face-to-face consultation and teleconsultation every three months.
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.

Locations

Country	Name	City	State
France	Centre Hospitalier Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patients and care providers satisfaction for tele consultation	Satisfaction of patients and care providers for tele-consults by telemedicine satisfaction Questionnaire (TSQ).; The TSQ is a 14-item questionnaire in its final version, the questionnaire items are scored on a five-point scale, from 1 being strongly disagree to 5 being strongly agree.. The internal consistency of the TSQ was 0.93, which is considered acceptable and indicates strong correlations between the items that make up the scale. Predictive validity supported the conclusion that the TSQ measured patient satisfaction with telemedicine (Pearson's correlation coefficient (r=0.45, P<0.05).	Measured after tele-consult (at 6 month M+6 and at 12 month M+12)
Secondary	Comparison between FEV1 measured at the department's respiratory functional exploration center and FEV1 measured with the Spirobank ® during the same in-hospital visit.	Comparison between FEV1 measured at the department's respiratory functional exploration center and FEV1 measured with the Spirobank ® during the same in-hospital visit in order to check that the difference between the two values does not exceed the margin of error of 5%.	At inclusion, 6month and 12 month
Secondary	effect on Patients and care providers quality of life	Quality of life of patients by Cystic fibrosis questionnaire revised(CFQ-R). The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R RSS and age group (<18 vs. >=18 years) were included as covariates in the analysis.	Measured at inclusion and after one year
Secondary	effect on Patients FEV1 (Forced expiratory volume)	FEV1 measured in start and at the end of the study	Measured at inclusion and after one year
Secondary	effect on Patients antibiotic cure number	Antibiotic cure during one year before start and after one year of the study	Measured at inclusion and after one year
Secondary	effect on patient's weight	Weight measured in start and at the end of the study	Measured at inclusion and after one year
Secondary	Effect on Patients call and mail to CF center	Number of calls and mails to CF center during one year before start and after one year of the study	Measured at inclusion and after one year