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

Sponsor

Current Health (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT05009485

Collaborator

South Shore Hospital (Other)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease Community-acquired Pneumonia	Device: Current Health platform	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Number of participants with a hospital readmission [up to 30 days]

Secondary Outcome Measures

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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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