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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05009485
• Other study ID #: SSH_2021
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: November 2021
• Source: Current Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Community-acquired Pneumonia
• Lung Diseases
• Lung Diseases, Obstructive
• Pneumonia
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Current Health	South Shore Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Number of participants with a hospital readmission		up to 30 days
Secondary	Time to service use		up to 30 days
Secondary	Rate of clinical visits	telehealth and/or ambulatory visits	up to 30 days
Secondary	Length of Stay	original and subsequent readmissions or emergency department attendance	up to 30 days
Secondary	Rate of Mortality		up to 30 days
Secondary	Rate of medication adherence		up to 30 days
Secondary	Progression of Disease	medication requirements, oxygen dependence, spirometric changes	up to 30 days