Primary Objective: Can an e-Health application, based on objective measurements, maintain the daily physical activity of COPD patients after a period of rehabilitation?Secondary Objective(s): • Are COPD patients motivated to use the e-Health…
ID
Source
Brief title
Condition
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Performed daily physical activity measured with the multisensor armband
(SenseWear).
Main parameter: number of steps per day.
Secondary outcome
• Dyspnoe (measured with the CRQ-SAS)
• Longfunction (FEV1, FVC after bronchodilatation)
• Physical capacity (measured with the six minute walk test)
• Body mass index (length/weight^2)
• Medication usage (measured by usageoverview of pharmacist)
• Exacerbations (number during the study)
• Use of mobile phone application (days used/ total study days (6 mos),
measured by the website)
• Effective guidance by health care provider (number of messages sent by
patient and physiotherapist)
Background summary
Currently, 64 million people suffer from COPD (Chronic Obstructive Pulmonary
Disease) and 3 million have died. The World Health Organizaion predicts that
COPD will become the third leading cause of death worldwide by 2030. Total
health care costs for the Netherlands in 200 are estimated at 280 million euro.
Patients with COPD show a decreased daily physical activity (DPA) compared with
healthy controls. Level of DPA is know to be related to hospital admittance and
mortality.
After a period of rehabilitation, a patient recieves advice on how to maintain
their DPA. Most of the COPD patients do not comply to this advice. This in turn
results in a vicious cycle of inactivity, increasing of symptoms, such as
dyspnoe, and deconditioning. It is important to find an intervention that will
maintain DPA after rehabilitation and stop this vicous cycle of deconditioning.
Study objective
Primary Objective:
Can an e-Health application, based on objective measurements, maintain the
daily physical activity of COPD patients after a period of rehabilitation?
Secondary Objective(s):
• Are COPD patients motivated to use the e-Health application for a long period
of time?
• Is the e-Health application effective in monitoring COPD patients by health
care providers?
• Does the e-health application have an effect on the daily physical activity,
lungfunction, dyspnoe, BMI en medicationusage of COPD patients?
Study design
this is a singleblind controlled study
Intervention
The intervention comprises the monitoring of the daily physical activity by
patients and their health care providers. The means are a mobile phone whith
accelerometer (smartphone) and a website. Patients wear the phone in their
pocket which measures their daily physical activity. They will use the phone as
if it is their own. The display of the phone will give the patient information
on their daily physical activitiy and tries to motivate/stimulate/compliment
them is this regard.
The data of the mobile phone is sent to a secured website. There, the health
care provider has an overview of the daily physical activity of all his
patients. He can determine the amount of steps a patients should perform per
day and the intensity. There is also the option of sending messages to the
patient.
Study burden and risks
Risks:
- The six minute walk test can be tiresome and can cause shortness of breath
- The armband can be uncomfortable while wearing and it can cause irritation of
the skin.
Burden:
4 hours for measurements and 28 days for measuring the daily physical activity
with the multisensory armband (SenseWear), which is worn around the upper arm.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
- Age 40 years and over
- Suffering from COPD (GOLD stage 2 and 3), 30% <= FEV1 < 80%, FEV1/FVC < 70% after bronchodilation.
- Completed rehabilitation program with a duration of at least 3 months
- Living at home independently
- signed informed consent
Exclusion criteria
- suffering from a co-morbidity that influences daily physical activity
- use of aid for mobility
- Stopped temporarily with rehabilitation program
- experienced an exacerbation resulting in hospitalization in the last 6 months
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 | NL37206.041.11 |