Technology-Enabled Self-Monitoring of Chronic Obstructive Pulmonary Disease With or Without Asynchronous Remote Monitoring: Protocol for a Randomized Controlled Trial

Vess Stamenova, Rebecca Yang, Katrina Engel, Kyle Liang, Florence van Lieshout, Elizabeth Lalingo, Angelica Cheung, Adam Erwood, Maria Radina, Allen Greenwald, Payal Agarwal, Aman Sidhu, R Sacha Bhatia, James Shaw, Roshan Shafai, Onil Bhattacharyya, Vess Stamenova, Rebecca Yang, Katrina Engel, Kyle Liang, Florence van Lieshout, Elizabeth Lalingo, Angelica Cheung, Adam Erwood, Maria Radina, Allen Greenwald, Payal Agarwal, Aman Sidhu, R Sacha Bhatia, James Shaw, Roshan Shafai, Onil Bhattacharyya

Abstract

Background: Chronic obstructive pulmonary disease (COPD) is the third leading cause of mortality worldwide. Reducing the number of COPD exacerbations is an important patient outcome and a major cost-saving approach. Both technology-enabled self-monitoring (SM) and remote monitoring (RM) programs have the potential to reduce exacerbations, but they have not been directly compared with each other. As RM is a more resource-intensive strategy, it is important to understand whether it is more effective than SM.

Objective: The objective of this study is to evaluate the impact of SM and RM on self-management behaviors, COPD disease knowledge, and respiratory status relative to standard care (SC).

Methods: This was a 3-arm open-label randomized controlled trial comparing SM, RM, and SC completed in an outpatient COPD clinic in a community hospital. Patients in the SM and RM groups recorded their vital signs (oxygen, blood pressure, temperature, and weight) and symptoms with the Cloud DX platform every day and were provided with a COPD action plan. Patients in the RM group also received access to a respiratory therapist (RT). The RT monitored their vital signs intermittently and contacted them when their vitals varied outside of predetermined thresholds. The RT also contacted patients once a week irrespective of their vital signs or symptoms. All patients were randomized to 1 of the 3 groups and assessed at baseline and 3 and 6 months after program initiation. The primary outcome was the Partners in Health scale, which measures self-management skills. Secondary outcomes included the St. George's Respiratory Questionnaire, Bristol COPD Knowledge Questionnaire, COPD Assessment Test, and modified-Medical Research Council Breathlessness Scale. Patients were also asked to self-report on health system usage.

Results: A total of 122 patients participated in the study, 40 in the SC, 41 in the SM, and 41 in the RM groups. Out of those patients, 7 in the SC, 5 in the SM, and 6 in the RM groups did not complete the study. There were no significant differences in the rates of study completion among the groups (P=.80).

Conclusions: Both SM and RM have shown promise in reducing acute care utilization and exacerbation frequencies. As far as we are aware, no studies to date have directly compared technology-enabled self-management with RM programs in COPD patients. We believe that this study will be an important contribution to the literature.

Trial registration: ClinicalTrials.gov NCT03741855; https://ichgcp.net/clinical-trials-registry/NCT03741855.

International registered report identifier (irrid): DERR1-10.2196/13920.

Keywords: chronic obstructive pulmonary disease; remote consultation; remote monitoring; self-monitoring.

Conflict of interest statement

Conflicts of Interest: None declared.

©Vess Stamenova, Rebecca Yang, Katrina Engel, Kyle Liang, Florence van Lieshout, Elizabeth Lalingo, Angelica Cheung, Adam Erwood, Maria Radina, Allen Greenwald, Payal Agarwal, Aman Sidhu, R Sacha Bhatia, James Shaw, Roshan Shafai, Onil Bhattacharyya. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 19.08.2019.

Figures

Figure 1
Figure 1
Patient flow through each arm of the study. A total of approximately 800 patients were screened for eligibility to obtain the final sample of 122 participants.
Figure 2
Figure 2
The chronic obstructive pulmonary disease action plan given to participants in the self- and remote monitoring group. The action plan was provided on a piece of paper and patients were asked to refer to it when needed. COPD: chronic obstructive pulmonary disease; CAT: COPD Assessment Test; mMRC: modified Medical Research Council; SpO2: peripheral oxygen saturation.

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