Geen registraties gevonden.
ID
Bron
Verkorte titel
Aandoening
- Luchtweginfecties
Synoniemen aandoening
Betreft onderzoek met
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Belangrijkste onderzoeksparameter/eindpunt:
Beoordeling van haalbaarheid en bruikbaarheid via User Experience
Questionnaires (UEQ's)
Ervaringen met PHEASANT door middel van semi-gestructureerd interview
Secundaire uitkomstmaten
Secundaire studieparameters/eindpunten:
Voedselinname via voedseldagboek
Symptomen van luchtwegaandoeningen: vermoeidheid en kortademigheid (via VAS)
Omgevingscondities: vochtigheid, temperatuur en luchtdruk
Andere parameters:
Patiëntdemografie (geslacht, leeftijd, gewicht, lengte, opleiding, enz.)
Ziekte-informatie (diagnose, symptomen)
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
The design of the study can be described as a longitudinal prospective
observational cohort investigation.
Inschatting van belasting en risico
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.
Publiek
De Boelelaan 1117
Amsterdam 1081HV
NL
Wetenschappelijk
De Boelelaan 1117
Amsterdam 1081HV
NL
Landen waar het onderzoek wordt uitgevoerd
Leeftijd
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
In onderzoek gebruikte producten en hulpmiddelen
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| CCMO | NL86911.018.24 |