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

Not Applicable

Recruiting

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

• Registration Number: NCT05249322
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-01-27
• Study First Submitted QC: 2022-02-18
• Study First Posted: 2022-02-21
• Study Start: 2022-03-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Follow-up alternating between face-to-face consultation and teleconsultation every three months	Follow-up alternating between face-to-face consultation and teleconsultation every three months.	Patients 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)

Primary Outcome Measures

Name	Time	Method
Change in Patients and care providers satisfaction after one year of alternated follow-up (hospital Consults and Tele-consult)	Measured at inclusion and after one year of follow up.	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) .

Secondary Outcome Measures

Name	Time	Method
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	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%.
effect on Patients and care providers quality of life	Measured at inclusion and after one year	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.
effect on Patients FEV1 (Forced expiratory volume)	Measured at inclusion and after one year	FEV1 measured in start and at the end of the study
Patients and care providers satisfaction for tele consultation	Measured after tele-consult (at 6 month M+6 and at 12 month M+12)	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).
effect on Patients antibiotic cure number	Measured at inclusion and after one year	Antibiotic cure during one year before start and after one year of the study
effect on patient's weight	Measured at inclusion and after one year	Weight measured in start and at the end of the study
Effect on Patients call and mail to CF center	Measured at inclusion and after one year	Number of calls and mails to CF center during one year before start and after one year of the study

Trial Locations

Locations (1)

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France