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

NCT05009485 | Withdrawn FDA Device

• 1 other identifier: SSH_2021
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease; Community-acquired Pneumonia

Keywords

wearable; Current Health platform; 30 day readmission

Outcome Measures

Primary Outcomes (1)

• Number of participants with a hospital readmission

  up to 30 days

Secondary Outcomes (6)

• Time to service use

  up to 30 days

• Rate of clinical visits

  up to 30 days

• Length of Stay

  up to 30 days

• Rate of Mortality

  up to 30 days

• Rate of medication adherence

  up to 30 days

Other Outcomes (1)

• Patient Satisfaction as assessed by the Telehealth Usability Questionnaire

  up to 30 days

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

Current Health platform DEVICE

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.

Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Current Health: lead
• South Shore Hospital: collaborator

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 17, 2021
• Study Start: January 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: November 17, 2021

Record last verified: 2021-11