Evaluating the Cloud DX Platform as a Tool for Self-management and Asynchronous Remote-monitoring of COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): Cloud Dx Kit with self-monitoring; Cloud Dx Kit with remote-monitoring
Intervention type(s): Device; Device
Intervention description(s): Patients in this group 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.; Patients in this group 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.
A respiratory therapist (RT) will be monitoring asynchronously patient 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: COPD; Chronic Obstructive Pulmonary Disease; Self-Management