1) To collect continuous data2) To extract and describe features, patterns and relationships in the data3) To quantify relationships between vital signs and activity variables or exposure to air pollution4) To identify features, patterns and…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) A dataset of heart rate, arterial oxygen saturation, physical activity,
time-activity patterns (GPS-location in time) and exposure to air pollution
data from 1-week continuous measurements of COPD patients and matched controls
using different types of sensors
2) A description of features, patterns and relationships in time series of
vital signs, activity variables and exposure to air pollution
3) A quantification of the relationships between vital signs and activity
variables or exposure to air pollution
4) An overview of features, patterns and relationships that differ for COPD
patients compared to matched controls
Secondary outcome
/
Background summary
Chronic Obstructive Pulmonary Disease (COPD) is highly prevalent and is
considered the fourth leading cause of death worldwide. Exacerbations are
typical stressful events in the natural history of COPD and have associations
with vital signs, activity variables and exposure to air pollution. mHealth
technologies are more and more frequently used in the management of chronic
diseases and can be applied to continuously measure these variables. The
hypothesis is that these continuous measurements contain useful information
that can provide additional insights in COPD.
Study objective
1) To collect continuous data
2) To extract and describe features, patterns and relationships in the data
3) To quantify relationships between vital signs and activity variables or
exposure to air pollution
4) To identify features, patterns and relationships in the data that are
COPD-specific
Study design
Observational case-control study
Study burden and risks
The participants will have to wear mobile sensors for 1 week, 24 hours per day:
an armband measuring physical activity, a wrist-worn pulse oximeter with finger
clip measuring heart rate and arterial oxygen saturation, a black carbon
aerosol monitor and a GPS travel recorder. Additionally, a chest strap
measuring physical activity and heart rate and an armband measuring physical
activity, heart rate and oxygen saturation should be worn for 2 non-consecutive
days. Previous studies with these devices did not report any adverse effects.
Though participants might experience some discomfort when wearing the sensors.
Boeretang 200
Mol 2400
BE
Boeretang 200
Mol 2400
BE
Listed location countries
Age
Inclusion criteria
- COPD as a primary diagnosis, diagnosed by a chest physician
- Clinically stable
- Treated according to the current international guidelines
- Permission for voluntary participation
Exclusion criteria
- Lack of motivation for voluntary participation in this study
- Receiving oxygen therapy
- Making use of a rollator to assist walking
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 | NL58079.100.16 |