In This Study, the Sponsor Would Like to Collaborate with Institution and Investigator to Aggregate Participants Data and to Pilot Its Software Algorithm Using Machine Learning and Threshold Based Methods for Predicting Exacerbations and Deterioration Within a 60 Days Period Post-discharge

Not yet recruiting

• Conditions: COPD

• Registration Number: NCT06798688
• Lead Sponsor: Respiree Pte Ltd

Brief Summary

In this study, the sponsor would like to collaborate with Institution and Investigator to aggregate participants data and to pilot its software algorithm using machine learning and threshold based methods for predicting exacerbations and deterioration within a 60 days period post-discharge.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-27
• Last Update Submitted: 2025-01-27
• Study First Posted: 2025-01-29
• Last Update Posted: 2025-01-29
• Study Start: 2025-03-01
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Subject age 18 or older

2. Receives all primary and specialty care at Institution

3. Participants will be enrolled at discharge (and not designate hospital or ED)

4. A history of one of the following diagnoses:

   a. c. Chronic obstructive pulmonary disease

5. At least two documented exacerbations of the above disease in the past 12 months as defined by the following corresponding criteria:

   a. Chronic obstructive pulmonary disease exacerbation: all three of (1) increase in frequency and severity or severity of cough, (2) increase in volume and/or change of character of sputum production, and (3) increase in dyspnea, and requiring treatment with short-acting bronchodilators, antibiotics, and oral or intravenous glucocorticoids.

6. Participants able to provide informed consent.

7. Participants will be enrolled at discharge (and not designate hospital or ED)

Exclusion Criteria

1. Participants with neuromuscular diseases and seizures
2. Participants enrolled in hospice care or life expectancy less than three months.
3. Participants living more than 60 miles away from Institution and Investigator
4. Participants with expected out of state travel within a 30-day period or travel to a location with no internet access.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identifying readmissions using respiratory biomarkers	60-days	To validate respiratory-based biomarkers in models to predict exacerbations - benchmarking to be done versus physician assess exacerbations, emergency department visits, hospitalizations and any other visit.

Secondary Outcome Measures

Name	Time	Method
Validate compliance and usability	60-days	To validate level of usability using self-assessed questionnaires required to get participants to follow-on