Cystic FibrosisFollowMucoNCT05249322
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
A study testing Follow-up alternating between face-to-face consultation and teleconsultation every three months. in people with Cystic Fibrosis, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Follow-up alternating between face-to-face consultation and teleconsultation every three months.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2022to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Isabelle Durieu, Pr contact
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69 495
Thomas VIDAL, 478865671 ext. +33, thomas.vidal@chu-lyon.fr
About this study
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
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.
- Conditions
- Cystic Fibrosis
- Being tested
- Follow-up alternating between face-to-face consultation and teleconsultation every three months.
- Keywords
- tele-medicine, cystic fibrosis, alternate follow-up
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up alternating between face-to-face consultation and teleconsultation every three months.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Follow-up alternating between face-to-face consultation and teleconsultation every three months | Experimental | 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) Receives: Other: Follow-up alternating between face-to-face consultation and teleconsultation every three months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at inclusion and after one year of follow up.
Secondary outcomes (7)
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: 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.
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%.
Measured: At inclusion, 6month and 12 month
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: Measured at inclusion and after one year
effect on Patients FEV1 (Forced expiratory volume)
FEV1 measured in start and at the end of the study
Measured: Measured at inclusion and after one year
effect on Patients antibiotic cure number
Antibiotic cure during one year before start and after one year of the study
Measured: Measured at inclusion and after one year
effect on patient's weight
Weight measured in start and at the end of the study
Measured: Measured at inclusion and after one year
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: Measured at inclusion and after one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start31 Mar 2022
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas VIDAL, Principal investigator, adult cystic fibrosis centre Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249322
- Sponsor's protocol ID
- 69HCL21_1354
- Other IDs
- 2022-A00134-39
- Acronym
- FollowMuco
- Status last verified
- Sep 2023
- First submitted
- 27 Jan 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05249322
- Acronym / sponsor ID
- FollowMuco / 69HCL21_1354
- Conditions
- Cystic Fibrosis
- Keywords
- tele-medicine, cystic fibrosis, alternate follow-up
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Follow-up alternating between face-to-face consultation and teleconsultation every three months | Experimental | Other: 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- patients with cystic fibrosis
- Patients treated with Kaftrio® since one year
- autonomous patients
- patients without cognitive disorders
- Patients voluntary for this follow up
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Follow-up alternating between face-to-face consultation and teleconsultation every three months |
Primary outcome
Change in Patients and care providers satisfaction after one year of alternated follow-up (hospital Consults and Tele-consult)
Time frame: 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) .
7 secondary outcomes
Patients and care providers satisfaction for tele consultation
Time frame: 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.
Time frame: At inclusion, 6month and 12 month
effect on Patients and care providers quality of life
Time frame: Measured at inclusion and after one year
effect on Patients FEV1 (Forced expiratory volume)
Time frame: Measured at inclusion and after one year
effect on Patients antibiotic cure number
Time frame: Measured at inclusion and after one year
effect on patient's weight
Time frame: Measured at inclusion and after one year
Effect on Patients call and mail to CF center
Time frame: Measured at inclusion and after one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Durieu, Pr contact
Thomas VIDAL principal investigator
adult cystic fibrosis centre Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow-up alternating between face-to-face consultation and teleconsultation every three months. in people with Cystic Fibrosis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas VIDAL (478865671 ext. +33, Thomas.vidal@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patients and care providers satisfaction after one year of alternated follow-up (hospital Consults and Tele-consult) (time frame: Measured at inclusion and after one year of follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.