Homebased connected devices combined with statistical process control for the early detection of respiratory exacerbations in patients with cystic fibrosis: a pilot study (Preprint)

Author:

Le Roux EnoraORCID,Ursino Moreno,Milovanovic Ivana,Picq Paul,Haignere Jeremie,Rault Gilles,Pougheon Bertrand DominiqueORCID,Alberti Corinne

Abstract

BACKGROUND

Currently, patients with cystic fibrosis do not routinely monitor their respiratory function at home.

OBJECTIVE

This study aims to assess the clinical validity of the use of different connected health devices at home measuring 5 physiological parameters to help preventing exacerbations on a personalised basis in a perspective of patient empowerment

METHODS

A multicenter interventional pilot study was led including 36 patients. The use of statistical process control (CUSUM) was applied to connected health devices measures with the objective to send patients alerts in relevant time on their individual risk of exacerbations. Associated patient education was delivered. Quantitative and qualitative data were collected

RESULTS

Half of the patients completed the protocol to the end. During the 12 months of interventions patients realised 6162 measures with connected health devices, 387 alerts were send and 33 exacerbations were reported. Alerts precision for exacerbation detection was weak for all parameters which may be partly related to the low compliance of patients with measurement. However a diminution in the median numbers of exacerbations was observed in patients when comparing their numbers 12 months before the inclusion and the 12 months of the intervention.

CONCLUSIONS

The use of connected health devices associated with statistical process control showed that these methods were very demanding for the patients and that this type of intervention was not acceptable for every patient. Avenues for improving the use of connected tools for early identification and better management of exacerbations are proposed

CLINICALTRIAL

NCT03304028

Publisher

JMIR Publications Inc.

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