Main Objective:To assess the feasibility and usability of the PHEASANT device as a home-monitoring tool across diverse age groups and pulmonary diseases, including asthma, cystic fibrosis (CF), primary ciliary dyskinesia (PCD), and chronic…
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter/endpoint:
- Feasibility and usability assessment by User Experience Questionnaires (UEQs)
- PHEASANT experiences by semi-structured interview
Secondary outcome
Secondary study parameters/endpoints:
- Food intake by food diary
- Respiratory disease symptoms: fatigue and dyspnoea (by VAS)
- Environmental conditions: humidity, temperature and air pressure
Other parameters:
- Patient demographics (gender, age, weight, height education etc.)
- Disease information (diagnosis, symptoms, medication use etc.)
Background summary
Chronic pulmonary diseases like asthma, cystic fibrosis (CF), primary ciliary
dyskinesia (PCD), and chronic obstructive pulmonary disease (COPD) impose a
substantial healthcare burden due to delayed detection and treatment of
respiratory symptoms. Early detection and intervention are critical for
preserving lung function and enhancing quality of life. However, current
clinic-based monitoring methods may miss subtle changes, necessitating
innovative approaches. Home-monitoring of exhaled breath holds promise for
improving early detection and management of exacerbations, ultimately improving
patient outcomes. This study aims to evaluate the feasibility and usability of
such breath-based monitoring tool, the PHEASANT device, in real-world settings
to address the user experience of this device in different populations.
Additionally, it seeks to enhance understanding of factors influencing device
performance and informing its potential integration into routine clinical
practice.
Study objective
Main Objective:
To assess the feasibility and usability of the PHEASANT device as a
home-monitoring tool across diverse age groups and pulmonary diseases,
including asthma, cystic fibrosis (CF), primary ciliary dyskinesia (PCD), and
chronic obstructive pulmonary disease (COPD).
Secondary Objectives:
To investigate factors that may influence PHEASANT measurements, including food
intake, environmental conditions (humidity, temperature, air pressure), device
placement within the household, and airway symptoms of the patients.
To evaluate the user experience of the PHEASANT device among individuals with
chronic pulmonary diseases, including satisfaction with device usability,
comfort, and convenience.
To gather feedback from participants regarding their experiences with using the
PHEASANT device and participating in home-based monitoring, including
suggestions for improvement.
Study design
The design of the study can be described as a longitudinal prospective
observational cohort investigation.
Study burden and risks
Participation in the study involves two visits at the patient*s home; one to
start the study period and a the second visit, after two weeks, to conclude the
study period by means of a semi-structured interview. Moreover, the study
involves daily usage of the PHEASANT device (11 days just once, 3 days six
times), completing questionnaires on symptoms (two questions a day) and dietary
intake (on 3 days only).
There are no benefits of participating in this study. Additionally, there are
no disadvantages for participants either, except for the time required to
perform the measurements with the PHEASANT and complete the questionnaires. The
risks of participating in this study are negligible.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
Being six years of age or older
and
Asthma diagnosis is based on: clinical symptoms in combination with treatment
according to the 2023 Global Initiative for Asthma (GINA) classification 2 or
higher.
or
CF diagnosis is based on: clinical symptoms in combination with an abnormal
sweat test (chloride > 60 mmol/l) and/or identification of mutations in both
alleles of the CFTR gene.
or
PCD diagnosis is based on: a combination of clinical symptoms, abnormal
movement of cilia on microscopic evaluation of respiratory epithelial biopsies
and epithelial cell cultures, or identification of an ultra-structural defect
in the cilia by electron microscopy.
or
COPD diagnosis is based on a: a combination of clinical symptoms as described
in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
AND forced spirometry showing the presence of a post-bronchodilator FEV1/FVC <
0.7.
and
Dutch speaking
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
If they have insufficient understanding of the Dutch language to fill out the
study questionnaires
If they have such severe pulmonary symptoms that they are admitted to a
hospital or care facility or need continuous oxygen administration. As this may
limit their ability to use the PHEASANT.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86911.018.24 |