Remote Monitoring of High-Risk Patients With Chronic Cardiopulmonary Diseases

NCT04825067 | Unknown

• 1 other identifier: 2021P000895
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 algorithm using machine learning and statistical models for predicting exacerbations and deterioration on 60 patients with cardiopulmonary diseases.

Conditions

Congestive Heart Failure; Asthma; Chronic Obstructive Pulmonary Disease; Cystic Fibrosis

Outcome Measures

Primary Outcomes (5)

• Respiratory rate (no. of breaths per minute)

  Respiratory rate will be one of the variables used in multivariable logistic regression and other models for prediction of acute exacerbations of chronic cardiopulmonary disorders.

  90 days

• Depth of breathing

  Depth of breathing will be one of the variables used in multivariable logistic regression and other models for prediction of acute exacerbations of chronic cardiopulmonary disorders.

  90 days

• Inhalation/exhalation times

  Inhalation/exhalation times will be one of the variables used in multivariable logistic regression and other models for prediction of acute exacerbations of chronic cardiopulmonary disorders.

  90 days

• Heart rate

  Heart rate will be one of the variables used in multivariable logistic regression and other models for prediction of acute exacerbations of chronic cardiopulmonary disorders.

  90 days

• Tissue oxygen saturation

  Tissue oxygen saturation will be one of the variables used in multivariable logistic regression and other models for prediction of acute exacerbations of chronic cardiopulmonary disorders.

  90 days

Study Arms (1)

Respiratory Sensor measurements

EXPERIMENTAL

The participant will receive 2 Respiratory Sensors and 1 gateway with wireless compatibility and a welcome packet with instructions for use, a reminder description of the study purpose and procedures, and research staff contact information. Research staff will contact participants to ensure appropriate setup of the Respiratory Sensor and training on proper use. Research staff will ask the subject to place the Respiratory Sensor on the top left-side of the chest. The Respiratory Sensor continuously collects and monitors respiratory data. The participant will be instructed to change each Respiratory Sensor after 24-48 hours. Subjects will be asked to charge each Respiratory Sensor once it is removed. Subjects will exit the study upon completion of the 90-day follow-up.

Device: Respiratory Sensor measurements

Interventions

Respiratory Sensor measurements DEVICE

The participant will receive 2 Respiratory Sensors and 1 gateway with wireless compatibility and a welcome packet with instructions for use, a reminder description of the study purpose and procedures, and research staff contact information. Research staff will contact participants to ensure appropriate setup of the Respiratory Sensor and training on proper use. Research staff will ask the subject to place the Respiratory Sensor on the top left-side of the chest. The Respiratory Sensor continuously collects and monitors respiratory data. The participant will be instructed to change each Respiratory Sensor after 24-48 hours. Subjects will be asked to charge each Respiratory Sensor once it is removed. Subjects will exit the study upon completion of the 90-day follow-up.

Respiratory Sensor measurements

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Institute of Bioengineering and Bioimaging (IBB): lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

Integrated Care Management Program

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure; Asthma; Pulmonary Disease, Chronic Obstructive; Cystic Fibrosis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pancreatic Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Central Study Contacts

Gurpreet Singh

CONTACT

+65 68247027; Gurpreet_Singh@ibb.a-star.edu.sg

Study Design

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

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 1, 2021
• Study Start: April 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 31, 2022
• Last Updated: September 29, 2022

Record last verified: 2022-09

Locations

US (1)