Efficacy of a physical activity coaching system for patients with COPD

In order to gain a good understanding of the research that has been done in the
area of Pysical Activity (PA) promotion for older COPD patients and to identify
the most appropriate literature for our purposes, literature scans were done
with keywords that contained in any order of combination: physical activity,
exercise, COPD, pulmonary rehabilitation, behavior change, quality of life.
The clinical literature revealed the benefits of physical activity and exercise
on a whole range of aspects ranging from *generally feeling better* to
*increased exercise tolerance in patients suffering from COPD*. However, only a
handful of papers discussed actually the promotion of physical activity, the
determinants of PA initiation and maintenance for COPD. In fact, the scans
revealed a gross lack of research on the topic for this particular patient
group.
Then a systematic literature study was done on the non-physical determinants of
PA in the older adult population * as papers related to COPD were scant, we
looked for populations with characteristic similar to COPD patients. With that
in mind, we found especially the literature with older populations possibly
suffering from other chronic conditions (like heart failure) to be most
relevant and applicable. We found that self-efficacy; personal barriers,
intrinsic and identified regulation, intention, attitudes and social support
were among the stronger determinants.
What was unexplored were the less cognitive and rational determinants and
aspects of PA and exercise for the older population. The literature scans
showed that especially the papers around and after 2000, the state-of-the-art
research on PA promotion in general (so chronically ill population, but also
relatively healthy populations that could benefit from physical activity like
kids in high school), showed an increased interest in the social and more
emotive aspects/determinants of physical activity, and in the direct
environmental factors. With the rise of truly patient centered designs, and the
notion of chaotic behavior change, newer intervention design methods are being
developed and explored.
Last year (2013) a pilot study wherein physical activity and well-being in 30
COPD patients (during 8-week rehabilitation and 4 weeks thereafter= 12 weeks in
total) was investigated for gaining insight into this population was performed.
Thereafter, we assessed the first software version of our coaching system in 15
COPD patients (at rehabilitation but also at home).This user trial (ICBE
2012-0362 Physical Activity Coaching system for COPD) lasted for two weeks (in
every patient) and assessed the use and opinion of the patients about the
system. This version only gave patients insight about their physical activity;
patients did not receive coaching yet.
Now we are incorporating the information we have collected by the user trial in
our coaching software and we want to study the efficacy of our second version
of the coaching software (including real coaching on the physical activity of
COPD patients) in 45 patients, compared to 45 patients without receiving
coaching (not receiving insight into their physical activities).

Primary objective:

To study physical activity of COPD patients before, during, and after pulmonary
rehabilitation. To evaluate whether and to what extent our designed physical
activity coaching system can support the maintainance of physical activity of
COPD patients at home after pulmonary rehabilitation, compared to a control
group without physical activity coaching (nor receiving insight into their
physical activities during the whole study).


Secondary objective(s):

To evaluate the use and acceptance of COPD patients to use an electronic
physical activity coaching program at home. We try to get a good insight into
how patients use the second prototype of the coaching system * navigation,
understanding of content, interaction, learnability etc.

Also we want to evaluate quality of life before, during, and after pulmonary
rehabilitationby several questionnaires (e.g. anxiety, depression, self
efficacy responses to physical activity, motivation, personality, mood). At the
end of the study we want to measure possible other explanatory factors for
differences in physical activity, such as commonly used transport, having a
dog, home settings (how do you live?), and exacerbation history. This will be
done via an exit interview, as performed by the Philips Researcher.

We intend to collect data about the physical activity of COPD patients before,
during, and after pulmonary rehabilitation. We want to evaluate if our designed
physical activity coaching system can support the maintenance of physical
activity of COPD patients at home after pulmonary rehabilitation, compared to a
control group without physical activity coaching. We will use Philips activity
monitors and questionnaires.
It is planned to test the coaching system in a 2 arm study. Both groups include
45 COPD patients.
The experimental group receives (after pulmonary rehab) physical activity
coaching. This group is compared to a control group, who doesn*t receive the
coaching part, but only wears the Philips activity monitor, and uploads his/her
data weekly.

The study is not blind, because participants may know in which group they are
(there are clear and open differences between the groups). However, patients
are included separately, and may not be aware of the existence of the other two
groups. (Double)-blindness is not important for this investigation, whereas we
expect little to no placebo effects in physical activity.

Patients are randomly allocated to the groups during rehabilitation, to avoid
group bias. All subjects receive a Philips sensor which they wear before
pulmonary rehabilitation (4 weeks), during pulmonary rehabilitation(8-16
weeks), and 8 weeks after pulmonary rehabilitation. Half of the subjects
receive (after pulmonary rehab) physical activity coaching.

To have in 2 arms physical activity data from 38 subjects for analysis and
assuming that a part of the subjects do not finalize pulmonary rehabilitation
or do not use the physical activity monitor or coaching system at home, it is
planned to start with 45 people in each arm.

Patients are identified for inclusion during baseline assessment a visit at
CIRO+. After consent is signed by the patients, patients will receive a Philips
physical activity sensor to measure their baseline activity level before
joining rehabilitation. Patients will fill in questionnaires on four occasions:
When the Philips sensor is supplied, at the start of pulmonary rehabilitation,
at the end of pulmonary rehabilitation, and at the end of the study (at
home).During the 8-16 weeks of rehabilitation, the patients will use the
Philips sensor, besides filling in some questionnaires (at start and end of
rehabilitation).

At home, half of the patients will next to the physical activity sensor receive
the Philips coaching system. Patients will use the system 8 weeks at home after
rehabilitation. At the end of these 8 weeks, patients will fill in some
questionnaires for the last time.
After 8 weeks at home the sensors, questionnaires, and coaching system will be
collected from the patient; done by the Philips Researcher.

At home, half of the patients (45 max) will, besides the physical activity
sensor, receive the Philips coaching system. Patients will use the system for 8
weeks at home after rehabilitation.
The other (control) group will not have an intervention, but will only upload
his/her PA data weekly.

We identified several risks related to: electrical safety, heat radiation,
interference with other devices, skin irritations, and falling. However, the
device used in this study is CE marked, battery operated, and used within
intended use, so these effects are not likely to occur and the risk is
considered negligible.

For the coaching programme we identified a risk that coaching possibly
stimulates COPD patient to be active beyond what he/she can physically
tolerate. The risk for this is indicated as extremely small by clinical
experts. Also expected harm in this case will not be severe this is also
confirmed clinical experts. Also we implement and additional mitigation for
this risk by setting the target activity threshold together with clinical
experts.
Also patients may feel anxiety or pressure by the fact that they are being
monitored. We mitigate this risk by providing proper information to the
patient. Also it is explained in the informed consent that although we are
monitoring, there will be no judgement made based on the collected
measurements.