Home-Care Bronchiectasis
Background
In 2021, PhysioAssist launched a feasibility study for the implementation of SIMEOX®, a bronchial drainage device for home use by people with bronchiectasis who have difficulty (because of lack of time, geographical distance, limited availability of health professionals etc.) accessing usual respiratory physiotherapy services. The device is linked to telecare physiotherapy so that the individual can be trained in how to use SIMEOX® correctly and to help maintain their motivation.
The study should also allow the level of compliance at home to be evaluated.
Promotor
PhysioAssist
Project coordination
IC@dom
Type of study
Medical devices study
Single-centre protocol
CHU de Grenoble, Toulouse et Nice
Sample size
22 participants
Study design
This feasibility and compliance study involved monitoring individuals at home for a period of 3 months. The aim was to determine the proportion of individuals who completed an average of at least 3 SIMEOX® sessions per week.
IC@dom was commissioned to provide comprehensive support to the PhysioAssist teams at every stage of the clinical investigation:
Project design
Coordination of physiotherapists and participants for the telecare
Drafting the protocol
Statistical analysis of data
Preparation of the e-CRF (electronic case report form)
Promotion of results
Results
The feasibility study revealed very high compliance with the SIMEOX® device by individuals, with a median score of 9.0 (7.9; 10.0) and a median frequency of use of 3.7 (1.8; 5.7) weekly sessions.
Following these encouraging results, PhysioAssist has launched the second stage of its clinical trial.
9
Median score
3.7
Median frequency of use
“The IC@dom CRO has expertise in clinical evaluation, particularly in the field of respiratory diseases. The team is proactive and highly competent: their advice and recommendations are always very relevant. We are delighted to be working with them.”
Laurent MORIN
Director of medical affairs – PhysioAssist
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