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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
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cystic Fibrosis in Children

Eligibility Criteria

10 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 30, 2021
    Last Updated
    April 7, 2021
    Sponsor
    Central Hospital, Nancy, France
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    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
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    Use of a Portable Spirometer in Pediatric Patients With Cystic Fibrosis at the Nancy CHRU: Feasibility Study

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