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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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05009485
Enrollment
0
Registered
2021-08-17
Start date
2022-01-01
Completion date
2024-05-01
Last updated
2021-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease, Community-acquired Pneumonia

Keywords

wearable, Current Health platform, 30 day readmission

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.

Interventions

DEVICECurrent 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.

Sponsors

South Shore Hospital
CollaboratorOTHER
Current Health
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of participants with a hospital readmissionup to 30 days

Secondary

MeasureTime frameDescription
Time to service useup to 30 days
Rate of clinical visitsup to 30 daystelehealth and/or ambulatory visits
Length of Stayup to 30 daysoriginal and subsequent readmissions or emergency department attendance
Rate of medication adherenceup to 30 days
Progression of Diseaseup to 30 daysmedication requirements, oxygen dependence, spirometric changes
Rate of Mortalityup to 30 days

Other

MeasureTime frameDescription
Patient Satisfaction as assessed by the Telehealth Usability Questionnaireup to 30 dayssubdomain of the Telehealth Usability Questionnaire that includes 4 questions measured on a 7-point Likert scale.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026