A Pre-post Intervention Study Evaluating Home-based Management of Patients With COPD or CAP
Primary Purpose
Chronic Obstructive Pulmonary Disease, Community-acquired Pneumonia
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Current Health platform
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring wearable, Current Health platform, 30 day readmission
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of participants with a hospital readmission
Secondary Outcome Measures
Time to service use
Rate of clinical visits
telehealth and/or ambulatory visits
Length of Stay
original and subsequent readmissions or emergency department attendance
Rate of Mortality
Rate of medication adherence
Progression of Disease
medication requirements, oxygen dependence, spirometric changes
Full Information
NCT ID
NCT05009485
First Posted
August 10, 2021
Last Updated
November 9, 2021
Sponsor
Current Health
Collaborators
South Shore Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05009485
Brief Title
A Pre-post Intervention Study Evaluating Home-based Management of Patients With COPD or CAP
Official Title
A Pre-post Intervention Study Evaluating Home-based Management of Patients With Chronic Obstructive Pulmonary Disease or Community Acquired Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Withdrawn
Why Stopped
study never started because reprioritization of clinical research efforts
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Current Health
Collaborators
South Shore Hospital
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Community-acquired Pneumonia
Keywords
wearable, Current Health platform, 30 day readmission
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Current Health platform
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with a hospital readmission
Time Frame
up to 30 days
Secondary Outcome Measure Information:
Title
Time to service use
Time Frame
up to 30 days
Title
Rate of clinical visits
Description
telehealth and/or ambulatory visits
Time Frame
up to 30 days
Title
Length of Stay
Description
original and subsequent readmissions or emergency department attendance
Time Frame
up to 30 days
Title
Rate of Mortality
Time Frame
up to 30 days
Title
Rate of medication adherence
Time Frame
up to 30 days
Title
Progression of Disease
Description
medication requirements, oxygen dependence, spirometric changes
Time Frame
up to 30 days
Other Pre-specified Outcome Measures:
Title
Patient Satisfaction as assessed by the Telehealth Usability Questionnaire
Description
subdomain of the Telehealth Usability Questionnaire that includes 4 questions measured on a 7-point Likert scale.
Time Frame
up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Pre-post Intervention Study Evaluating Home-based Management of Patients With COPD or CAP
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