A Pre-post Intervention Study Evaluating Home-based Management of Patients With COPD or CAP

A Pre-post Intervention Study Evaluating Home-based Management of Patients With Chronic Obstructive Pulmonary Disease or Community Acquired Pneumonia

Risk of rehospitalization within 30 days of discharge is higher than 20% in patients with chronic obstructive pulmonary disease (COPD) and up to 20% for patients with community acquired pneumonia (CAP). This pre-post intervention study aims to quantify the impact of continuous remote patient monitoring (RPM) on rates of hospital readmission for patients presenting with CAP or exacerbation of COPD and compare the intervention group to historical controls that did not have access to the intervention. We hypothesize that an intervention combining remote patient monitoring with the remote clinical services and escalation pathways available at SSH (including the Mobile Integrated Health (MIH) program) will reduce hospital readmission within the 30 days following hospital discharge compared to standard of care in this population.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Obstructive Pulmonary Disease; Community-acquired Pneumonia
• Intervention / Treatment: Device: Current Health platform

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 21 years or older
• confirmed diagnosis of moderate-severe COPD or community acquired pneumonia
• attendance at South Shore Hospital with an exacerbation of COPD / CAP
• fit for discharge to home

Exclusion Criteria:

• suspicion of COVID-19 or confirmed COVID-19 positive
• life-threatening exacerbation requiring invasive ventilation or prolonged stay in critical care (> 24 hours)
• unable/unwilling to use Current Health
• bilateral axillary lymph node dissection
• persistent atrial fibrillation
• heavy tattooing on upper arms
• discharged to skilled nursing facility
• no access to home or mobile telephone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants will be remotely monitored with the Current Health platform, respond to daily respiratory surveys, receive daily medication reminders and an action plan. Daily dashboard rounds and vital sign alarms from the continuously collected vital signs will be used to identify changes in health and escalated accordingly.	Device: Current Health platform; A remote patient monitoring system which includes a small footprint device and tablet, combined with an AI-powered, cloud-based system driving advanced real-time and predictive analytics related to a patient's clinical condition. The wearable records heart rate, respiratory rate, oxygen saturation, skin temperature and step count.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with a hospital readmission	up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to service use		up to 30 days
Rate of clinical visits	telehealth and/or ambulatory visits	up to 30 days
Length of Stay	original and subsequent readmissions or emergency department attendance	up to 30 days
Rate of Mortality		up to 30 days
Rate of medication adherence		up to 30 days
Progression of Disease	medication requirements, oxygen dependence, spirometric changes	up to 30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction as assessed by the Telehealth Usability Questionnaire	subdomain of the Telehealth Usability Questionnaire that includes 4 questions measured on a 7-point Likert scale.	up to 30 days

Collaborators and Investigators

• Sponsor: Current Health
• Collaborators: South Shore Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 17, 2021

Study Record Updates

• Last Update Posted (Actual): November 17, 2021
• Last Update Submitted That Met QC Criteria: November 9, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: wearable; Current Health platform; 30 day readmission
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pneumonia
• Other Study ID Numbers: SSH_2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No