The aim of this research is through feedback to increase physical activity of the patient and get a better distribution of activities over the day.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Following the main objective the following primary research question is:
Does activity increase in COPD patients, receiving feedback from the prototype
COPD dot COM system, measured in number of steps per day, compared with a group
of COPD patients without feedback?
Secondary outcome
Secondary questions are:
-Is the distribution of activities throughout the day more evenly distributed
in patients using the COPD dot COM application with feedback compared with a
group of patients who have received no feedback?
-What is the correlation between the two different measurements (pedometer and
MTX-W motion sensor)?
Background summary
Feedback to the COPD patient about his condition and physical activity plays an
important role in promoting self-management. Within the current care for
patients with COPD, there is a lack of insight into daily activities and lack
of understanding of the impact of physical training on the disease status. In
addition, health care providers are still working with paper patient files with
the disadvantage that they are not constantly updated and current information
is missing. That's why the "COPD dot COM" study was launched with the objective
to develop a prototype monitoring system for activity and symptoms in COPD
patients. The system can be tailored to individual needs of patients. Issues
within this study are the prevention of deterioration of disease status and
encouragement of an active lifestyle. The patient is supported and led by
Information and Communication Technology (ICT) in achieving these goals. In
addition, the system can give professionals involved timely insight so they can
give advice and exchange information among themselves.
Study objective
The aim of this research is through feedback to increase physical activity of
the patient and get a better distribution of activities over the day.
Study design
The COPD dot COM study is a proof of concept study which runs from October 2010
until January 2011. It is a randomized intervention study without invasive
measurements. One group will get feedback based on motion sensors, the other
group does not get feedback.
Intervention
Two groups of 16 patients will be formed. The control group wears a pedometer
during four weeks, 4 days of the week (Yamax DigiWalker 200).
The intervention group uses the same pedometer as the control group with the
COPD dot COM prototype system consisting of MTX-W motion sensor (Xsens) and
Personal Digital Assistant ([PDA] (HTC P3600/P3700) and a touchscreen (or their
own computer) linking to a Web portal.
The patients must wear both pedometer and MTX-W sensor and PDA around their
waist, from when they wake up until at least eight PM. In the intervention
group, the PDA provides feedback in the form of counseling. In addition, the
intervention group completes a daily diary of their symptoms on the portal.
Based on the subjective reports feedback about starting a course of
prednisolone and / or antibiotics is given. Both groups have to write down per
part of the day how many steps the pedometer measured.
Study burden and risks
The burden for patients is limited to wearing the pedometers and COPD dot COM
application. Based on feedback, the patients in the intervention group are
encouraged to change to a more even distribution of activities throughout the
day. In addition, the patients keep a diary which can provide feedback with
regard to taking a course of prednisolone and / or antibiotics in case of an
impending exacerbation. The self-treatment of an exacerbation can be regarded
as standard care, with minimal risk. The benefit to the patient is a better
physical condition as the altered movement pattern will be sustained after this
short proof of concept study.
Haaksbergerstraat 55
7533 ER Enschede
NL
Haaksbergerstraat 55
7533 ER Enschede
NL
Listed location countries
Age
Inclusion criteria
-A clinical diagnosis of stable COPD defined by GOLD criteria
-GOLD classification II-III
-Able to read, write and understand Dutch language
-Internet access at home
Exclusion criteria
-Exacerbation in four weeks prior to measurement
-Inability to control application
-Comorbidity which restricts movement activities
-Pathological changes which may affect activities of daily living (eg, stroke, osteoarthritis, arthritis, rheumatoid arthritis)
-Asthma
-Other present and active lung disease
-Use of oxygen
-Less than six weeks ago started to workout with the physiotherapist.
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 | NL33403.044.10 |
| Other | Volgt z.s.m. |