MUCOviscidose EXacerbation Outils Connectés Education Thérapeutique

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

Interventions

DEVICE

Connected Devices for 3 months

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.

BEHAVIORAL

Educationnal Intervention

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..

DEVICE

Connected Devices for 12 months

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.

OTHER

Interviews

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.

BEHAVIORAL

Refusal Questionnaires

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

Sponsors & Collaborators

• Fondation pour la Recherche Médicale

  collaborator OTHER

• Vertex Pharmaceuticals Incorporated

  collaborator INDUSTRY

• Fondation Ildys

  collaborator OTHER

• Institut National de la Santé Et de la Recherche Médicale, France

  lead OTHER_GOV

Principal Investigators

• Gilles RAULT, Ph · Fondation Ildys

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-20

Primary Completion

2020-06-18

Completion

2020-06-18

Countries

• France

Study Locations