MUCOviscidose EXacerbation Outils Connectés Education Thérapeutique

NCT03304028 | Terminated

• 2 other identifiers: C16-1192017-A00723-50
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 7

Brief Summary

Early detection of pulmonary exacerbations (PEx) in Cystic Fibrosis (CF) patients is important to quickly trigger treatment and reduce respiratory damage. The investigators hypothesize that using home-based connected devices (CDs) in educated patients applying Cumulative sum charts (CUSUM) to monitor physiological parameters (PP) and patients' perception reported (PRP), will allow early detection of PEx. Objective: to study clinical validity of using CDs and evaluate adherence and satisfaction in CF patients and teams Design: 3 phase multicenter study in 36 CF patients aged \>=12 years. Phase 1, patients are equipped during 3 months with CDs. PP and PRP to estimate CUSUM parameters are collected. In phase 2, patient's personalized educational plan to manage alerts is built. In phase 3, PP and PRP are collected during 12 months. Clinical validity, change in patients clinical data, quality of Life/Anxiety-Depression/Satisfaction, patients and teams' acceptance and adherence are assessed.

Conditions

Cystic Fibrosis

Keywords

Connected Devices; Pulmonary Exacerbations; Cumulative Sum (CUSUM) Chart

Outcome Measures

Primary Outcomes (1)

• Exacerbations (ExR) concordance

  Assesses agreement between the ExR episodes detected by the connected objects and the ExR episodes detected by the start date of the antibiotic treatment noted in the patient's medical record

  2 Years

Secondary Outcomes (20)

• Hospital Anxiety and Depression scale (HADS)

  Inclusion ; month 3 ; month 10 ; month 22

• Cystic Fibrosis Questionnaire-Revised (CFQ-R)

  Inclusion ; month 3 ; month 10 ; month 22

• Medical data : FEV1

  Inclusion ; month 3 ; month 10 ; month 13 ; month 16 ; month 19 ; month 22

• Medical data: Weight

  Inclusion ; month 3 ; month 10 ; month 13 ; month 16 ; month 19 ; month 22

• Medical data: Height

  Inclusion ; month 3 ; month 10 ; month 13 ; month 16 ; month 19 ; month 22

Study Arms (2)

Refusal Group

OTHER

Refusal Questionnaires Intervention: Clinic staff will email all patients or parents (pediatric settings) to introduce the study. A qualitative interview with 10 patients who declined to participate in the study will be conducted to identify the reason of refusal.

Behavioral: Refusal Questionnaires

Interventionnal Group

OTHER

Connected Devices for 3 months (36 patients will be equipped with CDs-spirometer, oxymeter, scales, podometer watch and AURA device for sleep quality and analyze) Educationnal Intervention Connected Devices for 12 months Interviews

Device: Connected Devices for 3 months; Behavioral: Educationnal Intervention; Device: Connected Devices for 12 months; Other: Interviews

Interventions

Connected Devices for 3 months DEVICE

Inclusion will be proposed at a follow-up visit by the child's or adult's referring doctor. A written informed consent form will be obtained. Quality of Life and Anxiety-Depression will be collected. Then, each included patient will be equipped with CDs-spirometer, oxymeter, scale and watch during 3 months for base-line.

Interventionnal Group

Educationnal Intervention BEHAVIORAL

After a first statistical analysis and interpretation (5 months), alert parameters for each patient are then fixed. An educational visit will be scheduled with patients and a personnalized action plan will be defined..

Interventionnal Group

Connected Devices for 12 months DEVICE

Each included patient will be re-equipped with CDs-spirometer, oxymeter, scale and watch during 12 months. If alerts occur, patients will be informed by email or SMS, with data transmission to the medical team who will not interfere. Patients should apply the shared action plan they learned. Quality of Life and Anxiety-Depression will be collected.

Interventionnal Group

Interviews OTHER

At the end, semi-structured interviews will be completed to explore confidence on the CDs, impact on the doctor-patient relationship, change in the workload of medical team…etc.

Interventionnal Group

Refusal Questionnaires BEHAVIORAL

Clinic staff will email all patients or parents (pediatric settings) to introduce the study. A qualitative interview with 10 patients who declined to participate in the study will be conducted to identify the reason of refusal

Refusal Group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years and over
• Cystic fibrosis confirmed by sweat test or genetic
• Able to understand and respect the protocol and its requirements
• Who signed the consent prior to any other procedure protocolFollowed in the same CF center during the study
• In clinically stable condition - no pulmonary exacerbation requiring intravenous antibiotics - in the previous 4 weeks)
• Prescribed at least one pulmonary medication (eg, inhaled mucolytic, inhaled or oral antibiotic therapy, hypertonic saline)
• Not undergone solid organ transplants
• With smartphone, computer or tablet connected to wifi access

You may not qualify if:

• Patient undergoing solid organ transplant
• Pregnancy or planned pregnancy during the period of the study
• Patients who don't use connected devices during the 3 first months will be excluded from the study.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead
• Fondation pour la Recherche Médicale: collaborator
• Vertex Pharmaceuticals Incorporated: collaborator
• Fondation Ildys: collaborator

Study Sites (7)

CF adults center - Hopital Albert Calmette

Lille, 59037, France

Location

CF adults center - Institut du Thorax

Nantes, 44093, France

Location

CF pediatrics center - Hopital Mère-Enfant

Nantes, 44093, France

Location

CF pediatrics center - Hopital Robert Debré

Paris, 75019, France

Location

CF adults and pediatrics center - American Memorial Hospital

Reims, 51092, France

Location

CF adults and pediatrics center- Perharidy

Roscoff, 29684, France

Location

CF pediatrics center - Hopital André Mignot

Versailles, 78150, France

Location

Related Publications (3)

• Le Roux E, Ursino M, Milovanovic I, Picq P, Haignere J, Rault G, Pougheon Bertrand D, Alberti C. Home-Based Connected Devices Combined With Statistical Process Control for the Early Detection of Respiratory Exacerbations by Patients With Cystic Fibrosis: Pilot Interventional Study With a Pre-Post Design. JMIR Form Res. 2024 Oct 28;8:e51753. doi: 10.2196/51753.

  PMID: 39467550 DERIVED

• Morsa M, Perrin A, David V, Rault G, Le Roux E, Alberti C, Gagnayre R, Pougheon Bertrand D. Experiences Among Patients With Cystic Fibrosis in the MucoExocet Study of Using Connected Devices for the Management of Pulmonary Exacerbations: Grounded Theory Qualitative Research. JMIR Form Res. 2024 Jan 23;8:e38064. doi: 10.2196/38064.

  PMID: 38261372 DERIVED

• Morsa M, Perrin A, David V, Rault G, Le Roux E, Alberti C, Gagnayre R, Pougheon Bertrand D. Use of Home-Based Connected Devices in Patients With Cystic Fibrosis for the Early Detection and Treatment of Pulmonary Exacerbations: Protocol for a Qualitative Study. JMIR Res Protoc. 2021 Aug 18;10(8):e14552. doi: 10.2196/14552.

  PMID: 34406124 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Gilles RAULT, Ph

  Fondation Ildys

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, longitudinal pilot study on cohort, in 3 phases

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: October 6, 2017
• Study Start: October 20, 2017
• Primary Completion: June 18, 2020
• Study Completion: June 18, 2020
• Last Updated: June 13, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)