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 for Cystic Fibrosis | NCT05249322

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

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

About this trial

This is an interventional health services research trial for Cystic Fibrosis focused on measuring tele-medicine, cystic fibrosis, alternate follow-up

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre Hospitalier Lyon SudRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Follow-up alternating between face-to-face consultation and teleconsultation every three months

Arm Description

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)

Outcomes

Primary Outcome Measures

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) .

Secondary Outcome Measures

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).

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%.

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.

effect on Patients FEV1 (Forced expiratory volume)

FEV1 measured in start and at the end of the study

effect on Patients antibiotic cure number

Antibiotic cure during one year before start and after one year of the study

effect on patient's weight

Weight measured in start and at the end of the study

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

Full Information

NCT ID

NCT05249322

First Posted

January 27, 2022

Last Updated

September 26, 2023

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT05249322

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 31, 2022 (Actual)

Primary Completion Date

March 31, 2024 (Anticipated)

Study Completion Date

March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

Keywords

tele-medicine, cystic fibrosis, alternate follow-up

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Follow-up alternating between face-to-face consultation and teleconsultation every three months

Arm Type

Experimental

Arm Description

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)

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Patients and care providers satisfaction after one year of alternated follow-up (hospital Consults and Tele-consult)

Description

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) .

Time Frame

Measured at inclusion and after one year of follow up.

Secondary Outcome Measure Information:

Title

Patients and care providers satisfaction for tele consultation

Description

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).

Time Frame

Measured after tele-consult (at 6 month M+6 and at 12 month M+12)

Title

Comparison between FEV1 measured at the department's respiratory functional exploration center and FEV1 measured with the Spirobank ® during the same in-hospital visit.

Description

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%.

Time Frame

At inclusion, 6month and 12 month

Title

effect on Patients and care providers quality of life

Description

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.

Time Frame