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

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ClinicalTrials.gov Identifier: NCT03741855
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Collaborator:
Markham Stouffville Hospital
Information provided by (Responsible Party):
Women's College Hospital

Brief Summary:

This study is an open-label, prospective, single-centred, randomized control trial, containing both a quantitative and a qualitative component and using a mixed methods design, to evaluate the impact of Cloud Dx kit, a device that can help patients monitor and manage Chronic obstructive pulmonary disease (COPD) at their home, on COPD and whether it 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 participant's 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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Device: Cloud Dx Kit with self-monitoring Device: Cloud Dx Kit with remote-monitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluating the Cloud DX Platform as a Tool for Self-management and Asynchronous Remote-monitoring of Chronic Obstructive Pulmonary Disease
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Remote-Monitoring Program
Cloud Dx kit with remote-monitoring
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.

Experimental: Self-Monitoring Program
Cloud Dx kit with self-monitoring
Device: 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



Primary Outcome Measures :
  1. Self-management and Activation [ Time Frame: 6 Months ]
    Measured with the Partners in Health Scale (PIHS)


Secondary Outcome Measures :
  1. Quality of Life and Respiratory symptoms [ Time Frame: 6 Months ]
    Assessed with the St. George's Respiratory Questionnaire (SGRQ)

  2. Patient Knowledge of COPD [ Time Frame: 6 Months ]
    Measured using the Bristol COPD Knowledge Questionnaire

  3. COPD Assessment [ Time Frame: 6 Months ]
    Measured by the COPD Assessment Test

  4. Breathlessness [ Time Frame: 6 Months ]
    Measured by the MRC Breathlessness Scale

  5. Total number of contacts/calls to the outpatient clinic and deaths [ Time Frame: 6 Months ]
  6. 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 ]
  7. Total length of stay for all admissions (in days) [ Time Frame: 6 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741855


Contacts
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Contact: Katrina Engel 905-472-7373 ext 6958 kengel@msh.on.ca
Contact: Roshan Shafai 905-472-7373 ext 1884 rshafai@msh.on.ca

Locations
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Canada, Ontario
Markham-Stouffville Hospital Recruiting
Markham, Ontario, Canada, LP3 7P3
Contact: Katrina Engel    905-472-7373 ext 6958    kengel@mshon.ca   
Sponsors and Collaborators
Women's College Hospital
Markham Stouffville Hospital
Investigators
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Principal Investigator: Sacha Bhatia Women's College Hospital

Publications:
Government of Canada, S. C. (2014, March 19). Estimating the prevalence of COPD in Canada: Reported diagnosis versus measured airflow obstruction. Retrieved October 24, 2017, from https://www.statcan.gc.ca/pub/82-003-x/2014003/article/11908-eng.htm.
Government of Canada, S. C. (2017, August 29). CANSIM - 105-0501 - Health indicator profile, annual estimates, by age group and sex, Canada, provinces, territories, health regions (2013 boundaries) and peer groups. Retrieved October 24, 2017, from http://www5.statcan.gc.ca/cansim/a26?lang=eng&id=1050501.

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Responsible Party: Women's College Hospital
ClinicalTrials.gov Identifier: NCT03741855     History of Changes
Other Study ID Numbers: WCHCDX-001
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results will be published in an academic peer-reviewed journal.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Link to protocol paper provided.
Access Criteria: Link to protocol paper provided.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Women's College Hospital:
COPD
Chronic Obstructive Pulmonary Disease
Self-Management

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases