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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-03-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Remote-Monitoring Program

Cloud Dx kit with remote-monitoring

Group Type EXPERIMENTAL

Cloud Dx Kit with remote-monitoring

Intervention Type DEVICE

* 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.

Self-Monitoring Program

Cloud Dx kit with self-monitoring

Group Type EXPERIMENTAL

Cloud Dx Kit with self-monitoring

Intervention Type DEVICE

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.

Standard of Care

Participants will not be provided with the Cloud DX kit or an action plan

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No