Evaluating the Cloud DX Platform as a Tool for Self-management and Asynchronous Remote-monitoring of COPD

October 24, 2019 updated by: Women's College Hospital

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.

Study Overview

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

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Markham, Ontario, Canada, LP3 7P3
        • Markham-Stouffville Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of COPD

Exclusion Criteria:

  • Diagnosis of other significant lung disease (eg. interstitial lung disease) or dementia
  • Lack of WiFi at home
  • Inability to speak English
  • Inability to use this technology due to physical or cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Remote-Monitoring Program
Cloud Dx kit with remote-monitoring
  • 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.
EXPERIMENTAL: Self-Monitoring Program
Cloud Dx kit with self-monitoring
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.
NO_INTERVENTION: Standard of Care
Participants will not be provided with the Cloud DX kit or an action plan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-management and Activation
Time Frame: 6 Months
Measured with the Partners in Health Scale (PIHS)
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life and Respiratory symptoms
Time Frame: 6 Months
Assessed with the St. George's Respiratory Questionnaire (SGRQ)
6 Months
Patient Knowledge of COPD
Time Frame: 6 Months
Measured using the Bristol COPD Knowledge Questionnaire
6 Months
COPD Assessment
Time Frame: 6 Months
Measured by the COPD Assessment Test
6 Months
Breathlessness
Time Frame: 6 Months
Measured by the MRC Breathlessness Scale
6 Months
Total number of contacts/calls to the outpatient clinic and deaths
Time Frame: 6 Months
Recorded by RT; deaths caregiver reported
6 Months
Total number of ED presentations, admissions to a hospital, exacerbations, visits to family doctor, number of nurse contacts, self-reported use of medication, self-reported smoking cessation
Time Frame: 6 Months
self-reported
6 Months
Total length of stay for all admissions (in days)
Time Frame: 6 Months
self-reported
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sacha Bhatia, Women's College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ACTUAL)

March 31, 2019

Study Completion (ACTUAL)

March 31, 2019

Study Registration Dates

First Submitted

October 4, 2018

First Submitted That Met QC Criteria

November 12, 2018

First Posted (ACTUAL)

November 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 29, 2019

Last Update Submitted That Met QC Criteria

October 24, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Results will be published in an academic peer-reviewed journal.

IPD Sharing Time Frame

Link to protocol paper provided.

IPD Sharing Access Criteria

Link to protocol paper provided.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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