Status:
UNKNOWN
Remote Monitoring of High-Risk Patients With Chronic Cardiopulmonary Diseases
Lead Sponsor:
Institute of Bioengineering and Bioimaging (IBB)
Collaborating Sponsors:
Massachusetts General Hospital
Conditions:
Congestive Heart Failure
Asthma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In this project, Institute of Bioengineering \& Bioimaging (IBB), A\*STAR would like to collaborate with Massachusetts General Hospital to aggregate patient data and to further develop its software al...
Detailed Description
Exacerbations of chronic cardiopulmonary diseases are a major cause of morbidity and mortality worldwide. There are an estimated 23 million patients with heart failure worldwide, and the prevalence of...
Eligibility Criteria
Inclusion
- Subject age 18 or older
- Receives all primary and specialty care within the MassGeneral Brigham system
- A history of one of the following diagnoses:
- Asthma
- Cystic Fibrosis
- Chronic obstructive pulmonary disease
- Congestive heart failure
- At least four documented exacerbations of the above disease in the past 12 months as defined by the following corresponding criteria:
- a. Asthma exacerbation: i. a minimum 3-day course of oral steroids ii. for patients on chronic steroids, an increased dose of steroids.
- b. Cystic fibrosis exacerbation: a minimum 7-day course of systemic antibiotics (not including any chronic suppressive antibiotics).
- c. 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.
- d. Congestive heart failure exacerbation: volume overload (as evidenced by weight gain or elevated BNP \[\>100 pg/mL\]/NT-proBNP \[\>300 pg/mL)) plus dyspnea plus diuretic treatment (new or increase from baseline).
- Subject able to provide informed consent.
Exclusion
- Subjects with a history of adhesive or tape allergy or skin reaction.
- Subjects with pacemaker, Automatic Implantable Cardioverter Defibrillator (AICD) and other implantable electronic devices.
- Subjects with neuromuscular disease, seizures and/or Parkinson's disease.
- Subjects with expected out of state travel within a 90-day period or travel to a location with no internet access.
- Subjects enrolled in hospice care or life expectancy less than three months.
- Subjects living more than 60 miles away from Massachusetts General Hospital. -
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04825067
Start Date
April 1 2022
End Date
December 31 2022
Last Update
September 29 2022
Active Locations (1)
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1
Integrated Care Management Program
Boston, Massachusetts, United States, 02114