Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Evaluating the Cloud DX Platform as a Tool for Self-management and Asynchronous Remote-monitoring of Chronic Obstructive Pulmonary Disease
This study is an open-label, prospective, single-centre, randomized controlled trial,
containing both a quantitative and a qualitative component and using a mixed-methods design.
The study evaluates the impact of Cloud Dx kit, a device that can allows patients to monitor
and manage Chronic Obstructive Pulmonary Disease (COPD) at their home. The study evaluates
whether using Cloud Dx improves patients' COPD symptoms, ability to manage COPD, and quality
of life.
It is anticipated that there will be 123 participants enrolled in this study across two
experimental arms and one control arm. Participants will be in the study for 6 months and the
study will run for 1 year a Markham-Stouffville Hospital. The primary outcome is the
participants' self-management and activation which will be measured using The Partners in
Health (PIH) scale, a validated scale measuring the current status of self-management, with
items on knowledge of the condition and skills to monitor and respond to symptoms.
This study is an open-label, prospective, single-centre, randomized controlled trial,
containing both a quantitative and a qualitative component and using a mixed-methods design.
The study evaluates the impact of Cloud Dx kit, a device that can allows patients to monitor
and manage Chronic Obstructive Pulmonary Disease (COPD) at their home. The study evaluates
whether using Cloud Dx improves patients' COPD symptoms, ability to manage COPD, and quality
of life.
COPD is a pervasive disease that is estimated to affect 2.6 million Canadians (17%) aged 35
to 79 costing the healthcare system in Canada $1.5 billion annually. Ontarians living with
COPD are frequent users of the health care system and account for 24% of hospital admissions
and 24% of emergency department (ED) visits. COPD is responsible for the highest percentage
(18.8%) of 30-day re-admissions to ED in the province.
A recent Cochrane review and meta-analysis concluded that remote monitoring has shown promise
in reducing acute care utilization and reducing the number of exacerbations in COPD patients.
While many studies have examined the effects of remote-monitoring, few studies have looked at
how self-monitoring without clinical oversight affects patients' self-management skills and
quality of life. Our goal is to compare a group of patients that are in both self- and
remote-monitoring to a group of patients that are only in a self-monitoring program and
compare each relative to a standard care group.
The technology used in this study is the Cloud Dx Connect Health Kit which will be used as a
tool for self-monitoring and asynchronous remote-monitoring. It consists of a custom Tablet
computer, Pulsewave® wrist cuff monitor, Oximeter, Scale and Therometer. Participants will
use the kit to record daily their physiological and symptom readings.
This study will take place at Markham-Stoufville hospital with most patients being recruited
from the Outpatient COPD Clinic (Respiratory Health-COPD Clinic) and will include patients
who have a clinical diagnosis of COPD that has been diagnosed by their respirologist as per
clinical guidelines. Recruitment will be ongoing until 123 patients have been recruited for
the intervention phase. Once enrolled, participants will be randomized into one of three
arms:
1. Self-Management group: Participants in this group will receive the Cloud Dx kit at the
start of the study and will continue using it for 6 months. They will be recording their
vitals and symptoms with the Cloud DX platform everyday and will be provided with an
action-plan that instructs them on what to do in response to their readings.
2. Remote-Monitoring group: Participants in this group will receive the Cloud Dx kit at the
start of the study and will continue using it for 6 months. They will be recording their
vitals and symptoms with the Cloud DX platform everyday and will be provided with an
action-plan that instructs them on what to do in response to their readings. In
addition, a respiratory therapist (RT) will be monitoring asynchronously their vitals
and contacting them when their vitals exceed pre-determined thresholds. The RT will also
check on patients once a week irrespective of the value of the vitals.
3. Standard of care group: Participants will not be provided with a technology or an action
plan (as the action plan is based on vitals and symptoms).
Primary and secondary outcomes will be assessed through a series of questionnaires at 3
time-points by all participants: at baseline, 3 months and 6 months.In addition, participants
will also complete a demographic questionnaire at the initial visit.
Participants who expressed interest in the qualitative component will be invited to complete
a qualitative interview. This qualitative process evaluation will occur alongside the
quantitative component and will include 5 participants from the remote-monitoring group and 5
participants from the self-monitoring group. Healthcare providers involved in the care of
participants will also be approached for participation in this evaluation process as well as
upon study completion and will ideally include a sample of up to 5 providers and up to 5
hospital administrators and clinic managers
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