Use of a Portable Spirometer in Pediatric Patients With Cystic Fibrosis at the Nancy CHRU: Feasibility Study (SPIROMUCO)
Primary Purpose
Cystic Fibrosis in Children
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Spirobank Smart
Sponsored by
About this trial
This is an interventional health services research trial for Cystic Fibrosis in Children
Eligibility Criteria
Inclusion Criteria:
- Patients with a cystic fibrosis diagnosis confirmed by a sweat chloride measurement ≥ 60 mmol/L
- Age between 10 and 20 years at enrolment
- Able to perform spirometry
- Having a smartphone
- Written consent adapted to the age
- Affiliated with a social insurance
Exclusion Criteria:
- Antibiotic therapy for a pulmonary exacerbation in the 2 weeks before enrollment
- Lung transplantation (past or future)
- Colonization with Bulkholderia cepacia in the last 2 years
- Absence of contentment
- Inability to access technology required to transmit home spirometry data
- Inability to speak and read French well enough to understand the use of the home spirometry and to complete the questionaries
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients using the Spirobank Smart
Arm Description
Use of a portable spirometry
Outcomes
Primary Outcome Measures
The observance of the realization of a follow up of pulmonary function in a cohort of cystic fibrosis's pediatric patients
Observance = the percentage (%) of measures realised during the 3 months, (number of measures done/ number of measures expected to be done according to the protocol)
Secondary Outcome Measures
The workload of managing the alerts
The number of alerts received by each doctor and the number and therapeutic's changes following these alerts
Full Information
NCT ID
NCT04837911
First Posted
March 30, 2021
Last Updated
April 7, 2021
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT04837911
Brief Title
Use of a Portable Spirometer in Pediatric Patients With Cystic Fibrosis at the Nancy CHRU: Feasibility Study
Acronym
SPIROMUCO
Official Title
Use of a Portable Spirometer in Pediatric Patients With Cystic Fibrosis at the Nancy CHRU: Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Anticipated)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
April 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Respiratory diseases (asthma, cystic fibrosis, COPD…) need for the diagnosis and the follow-up the use of pulmonary function tests. These technics which are used since the nineteenth century and their discovery by Hutchinson, are now currently performed in pediatrics hospitals but they require trained personnel. Spirometry can be a difficult technic, especially for children. The accuracy and repeatability depend on many factors: equipment, patient effort, supervision and encouragement of a technician. A longitudinal follow up of measures can be good especially in pediatric populations, where children have generally more difficulties recognising their symptoms.
Cystic fibrosis is a severe genetic chronic disease, that affects 1/4500 birth in France.
It's a multi system disease that affects the respiratory system, with a decline in lung function over the time and consecutive to pulmonary exacerbations, the digestive system (malabsorption of fat and vitamins) and the endocrine system (diabetes).
Pulmonary function is an important clinical indicator of the health of individuals with cystic fibrosis.
Close monitoring of patient health with daily recording of physical measurements and symptoms didn't have a negative impact, home spirometry function test could help detect earlier a decline of the lung function and pulmonary exacerbations.
Frequent exacerbations are associated with morbidity, mortality, accelerated decline in lung function and a decreased quality of life. They are also a major driver of health costs.Their early detection is a goal.
Children with cystic fibrosis have more difficulties recognizing symptoms of exacerbations.
Few studies in pediatric showed a good observance in realizing home spirometry, especially in young patients and those living far from the hospital and with a good satisfaction.
Daily monitoring of lung function is probably too tedious for children who already have lots of medication.
Medical adhesion of adolescent's patients is often suboptimal, compared with younger patients. But it's during this period that the decline of the respiratory function is the most important, with its principal cause: pulmonary exacerbations. Frequent home pulmonary function test is possible and can improve medication adherence without adding too much time, but there was no change in the decline of the FEV1 and the number of pulmonary exacerbations.
The association of home monitoring of lung function and a symptom questionary (cough, sputum and dyspnea) can predict exacerbation with a good specificity and sensibility.
The Mir Spirobank Smart is a bluetooth connected device, permitting patients to realize spirometry at home with a smartphone.
The accuracy of the Spirobank Smart compared with a spirometry in a hospital showed a good correlation (asthma and COPD population), if it's used by trained personnel.
The aim of this study is to determine the feasibility of a home respiratory monitoring in a pediatric cohort of patients with cystic fibrosis and the satisfaction of the kids, the parents and the team of the CRCM.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis in Children
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The spirometers have been purchased with charitable donations, that's why we have 35 of them.
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients using the Spirobank Smart
Arm Type
Other
Arm Description
Use of a portable spirometry
Intervention Type
Device
Intervention Name(s)
Spirobank Smart
Intervention Description
Patients using the Spirobank Smart
Primary Outcome Measure Information:
Title
The observance of the realization of a follow up of pulmonary function in a cohort of cystic fibrosis's pediatric patients
Description
Observance = the percentage (%) of measures realised during the 3 months, (number of measures done/ number of measures expected to be done according to the protocol)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The workload of managing the alerts
Description
The number of alerts received by each doctor and the number and therapeutic's changes following these alerts
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with a cystic fibrosis diagnosis confirmed by a sweat chloride measurement ≥ 60 mmol/L
Age between 10 and 20 years at enrolment
Able to perform spirometry
Having a smartphone
Written consent adapted to the age
Affiliated with a social insurance
Exclusion Criteria:
Antibiotic therapy for a pulmonary exacerbation in the 2 weeks before enrollment
Lung transplantation (past or future)
Colonization with Bulkholderia cepacia in the last 2 years
Absence of contentment
Inability to access technology required to transmit home spirometry data
Inability to speak and read French well enough to understand the use of the home spirometry and to complete the questionaries
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurélie Mrs TATOPOULOS, Doctor
Phone
033383154556
Email
au.tatopoulos@chru-nancy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurélie Mrs TATOPOULOS, Doctor
Organizational Affiliation
CHRU Nancy, France
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32592537
Citation
Kruizinga MD, Essers E, Stuurman FE, Zhuparris A, van Eik N, Janssens HM, Groothuis I, Sprij AJ, Nuijsink M, Cohen AF, Driessen GJA. Technical validity and usability of a novel smartphone-connected spirometry device for pediatric patients with asthma and cystic fibrosis. Pediatr Pulmonol. 2020 Sep;55(9):2463-2470. doi: 10.1002/ppul.24932. Epub 2020 Jul 8.
Results Reference
background
PubMed Identifier
28229102
Citation
Shakkottai A, Nasr SZ. The Use of Home Spirometry in Pediatric Cystic Fibrosis Patients: Results of a Feasibility Study. Glob Pediatr Health. 2017 Feb 2;4:2333794X17690315. doi: 10.1177/2333794X17690315. eCollection 2017.
Results Reference
background
PubMed Identifier
1579374
Citation
Finkelstein SM, Wielinski CL, Kujawa SJ, Loewenson R, Warwick WJ. The impact of home monitoring and daily diary recording on patient status in cystic fibrosis. Pediatr Pulmonol. 1992 Jan;12(1):3-10. doi: 10.1002/ppul.1950120104.
Results Reference
background
PubMed Identifier
20565480
Citation
Sarfaraz S, Sund Z, Jarad N. Real-time, once-daily monitoring of symptoms and FEV in cystic fibrosis patients--a feasibility study using a novel device. Clin Respir J. 2010 Apr;4(2):74-82. doi: 10.1111/j.1752-699X.2009.00147.x.
Results Reference
background
PubMed Identifier
29457700
Citation
Shakkottai A, Kaciroti N, Kasmikha L, Nasr SZ. Impact of home spirometry on medication adherence among adolescents with cystic fibrosis. Pediatr Pulmonol. 2018 Apr;53(4):431-436. doi: 10.1002/ppul.23950. Epub 2018 Feb 19.
Results Reference
background
PubMed Identifier
28955051
Citation
van Horck M, Winkens B, Wesseling G, van Vliet D, van de Kant K, Vaassen S, de Winter-de Groot K, de Vreede I, Jobsis Q, Dompeling E. Early detection of pulmonary exacerbations in children with Cystic Fibrosis by electronic home monitoring of symptoms and lung function. Sci Rep. 2017 Sep 27;7(1):12350. doi: 10.1038/s41598-017-10945-3. Erratum In: Sci Rep. 2018 Dec 13;8(1):17946.
Results Reference
background
PubMed Identifier
22269344
Citation
Degryse J, Buffels J, Van Dijck Y, Decramer M, Nemery B. Accuracy of office spirometry performed by trained primary-care physicians using the MIR Spirobank hand-held spirometer. Respiration. 2012;83(6):543-52. doi: 10.1159/000334907. Epub 2012 Jan 21.
Results Reference
background
Learn more about this trial
Use of a Portable Spirometer in Pediatric Patients With Cystic Fibrosis at the Nancy CHRU: Feasibility Study
We'll reach out to this number within 24 hrs