Present and evaluate a novel monitoring system for 24/7 continuously monitoring of COPD patients, using cHealth technologies.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Evaluation of the opportunities of a novel monitoring system for continuously,
24/7 monitoring of COPD patients, using cHealth technologies. Evaluation will
be based on the ability of the system to provide new insights into the
management and treatment of COPD.
Secondary outcome
- Evaluation of data usability
- Examination of the accuracy of heart rate measurements from pulse oximetry
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. Exacerbations can lead
to hospitalisations. Current treatment policy of COPD, including frequent
hospitalisation, results in a high economic burden. Prediction of exacerbations
could lead to prevention of hospitalisations, which would improve the quality
of life of patients with COPD and reduce the economic burden of COPD.
Studies using connected health (cHealth) solutions for exacerbation prediction
are promising. Furthermore, cHealth solutions can be used to closely monitor
COPD patients, making it possible to closely manage the treatment of the
disease. In this study, a novel monitoring system for continuous, 24/7
monitoring of COPD patients using cHealth technologies will be presented and
evaluated.
Study objective
Present and evaluate a novel monitoring system for 24/7 continuously monitoring
of COPD patients, using cHealth technologies.
Study design
Observational case-control study
Study burden and risks
The participants will have to wear a monitoring system for one week, 24 hours
per day. The monitoring system consists of an armband measuring physical
activity, a wrist-worn pulse oximeter with finger clip measuring heart rate and
oxygen saturation, a black carbon aerosol monitor and a GPS travel recorder.
The finger clip might hinder in some daily activities. The black carbon aerosol
monitor and GPS travel recorder cannot be worn on-body and have to be carried
along. Furthermore, one black carbon aerosol monitor will be placed in the home
of the participants. Previous studies with these devices did not report any
adverse effects.
Additionally, a chest strap measuring heart rate, physical activity and
respiratory rate should be worn for 2 non-consecutive days during waking hours.
The participant might experience some discomfort while wearing the chest strap.
Previous studies with the device did not report any adverse effects.
At the end of the measuring week, a structured evaluation interview will be
performed.
Hornerheide 1
NM Horn 6085
NL
Hornerheide 1
NM Horn 6085
NL
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
- Cognitive impairment (MMSE score < 24)
- Receiving oxygen therapy
- Making use of a rollator to assist walking
- Not having a partner
- Having a partner who:
° Is not willing to participate
° Is diagnosed of COPD
° Is not living on the same address
° Has cognitive impairment (MMSE score < 24)
° Has serious medical conditions that could prohibit mobility/physical activity (e.g. severe cardiovascular conditions, cancers, severe orthopedic problems)
Design
Recruitment
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 | NL57234.100.16 |