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

NCT03741855 | Completed

• 1 other identifier: WCHCDX-001
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Chronic Obstructive Pulmonary Disease; Self-Management

Outcome Measures

Primary Outcomes (1)

• Self-management and Activation

  Measured with the Partners in Health Scale (PIHS)

  6 Months

Secondary Outcomes (7)

• Quality of Life and Respiratory symptoms

  6 Months

• Patient Knowledge of COPD

  6 Months

• COPD Assessment

  6 Months

• Breathlessness

  6 Months

• Total number of contacts/calls to the outpatient clinic and deaths

  6 Months

Study Arms (3)

Remote-Monitoring Program

EXPERIMENTAL

Cloud Dx kit with remote-monitoring

Device: Cloud Dx Kit with remote-monitoring

Self-Monitoring Program

EXPERIMENTAL

Cloud Dx kit with self-monitoring

Device: Cloud Dx Kit with self-monitoring

Standard of Care

NO INTERVENTION

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

Interventions

Cloud Dx Kit with self-monitoring 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.

Self-Monitoring Program

Cloud Dx Kit with remote-monitoring 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.

Remote-Monitoring Program

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of COPD

You may not qualify if:

• 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

Sponsors & Collaborators

• Women's College Hospital: lead
• Markham Stouffville Hospital: collaborator

Study Sites (1)

Markham-Stouffville Hospital

Markham, Ontario, LP3 7P3, Canada

Location

Related Publications (7)

• Evans J, Chen Y, Camp PG, Bowie DM, McRae L. Estimating the prevalence of COPD in Canada: Reported diagnosis versus measured airflow obstruction. Health Rep. 2014 Mar;25(3):3-11.

  PMID: 24648134 BACKGROUND

• Gershon AS, Guan J, Victor JC, Goldstein R, To T. Quantifying health services use for chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2013 Mar 15;187(6):596-601. doi: 10.1164/rccm.201211-2044OC. Epub 2013 Jan 17.

  PMID: 23328526 BACKGROUND

• 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.

  BACKGROUND

• McLean S, Nurmatov U, Liu JL, Pagliari C, Car J, Sheikh A. Telehealthcare for chronic obstructive pulmonary disease: Cochrane Review and meta-analysis. Br J Gen Pract. 2012 Nov;62(604):e739-49. doi: 10.3399/bjgp12X658269.

  PMID: 23211177 BACKGROUND

• Mittmann N, Kuramoto L, Seung SJ, Haddon JM, Bradley-Kennedy C, Fitzgerald JM. The cost of moderate and severe COPD exacerbations to the Canadian healthcare system. Respir Med. 2008 Mar;102(3):413-21. doi: 10.1016/j.rmed.2007.10.010. Epub 2007 Dec 20.

  PMID: 18086519 BACKGROUND

• Stamenova V, Liang K, Yang R, Engel K, van Lieshout F, Lalingo E, Cheung A, Erwood A, Radina M, Greenwald A, Agarwal P, Sidhu A, Bhatia RS, Shaw J, Shafai R, Bhattacharyya O. Technology-Enabled Self-Management of Chronic Obstructive Pulmonary Disease With or Without Asynchronous Remote Monitoring: Randomized Controlled Trial. J Med Internet Res. 2020 Jul 30;22(7):e18598. doi: 10.2196/18598.

  PMID: 32729843 DERIVED

• Stamenova V, Yang R, Engel K, Liang K, van Lieshout F, Lalingo E, Cheung A, Erwood A, Radina M, Greenwald A, Agarwal P, Sidhu A, Bhatia RS, Shaw J, Shafai R, Bhattacharyya O. Technology-Enabled Self-Monitoring of Chronic Obstructive Pulmonary Disease With or Without Asynchronous Remote Monitoring: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Aug 19;8(8):e13920. doi: 10.2196/13920.

  PMID: 31429418 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sacha Bhatia

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: November 15, 2018
• Study Start: January 1, 2018
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: October 29, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Link to protocol paper provided.
• Access Criteria: Link to protocol paper provided.

Locations

CA (1)