Assessment of Utility of accelerateIQ in the Care of Patients Participating in a Pulmonary Rehabilitation Program (GASSP)

The proposed study seeks to assess the performance of continuous biosensor data and machine learning analytics in assessment of health patient status in a pulmonary rehabilitation program.

It is hypothesized that using continuous physiologic biosensor data and machine learning analytics to detect changes in physiology may play a role in managing patients in the pulmonary rehabilitation setting.

Study Overview

• Status: Terminated
• Conditions: Pulmonary Rehabilitation; COPD
• Intervention / Treatment: Other: pinpointIQ

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Evanston, Illinois, United States, 60201
      • NorthShore University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will be patients diagnosed with COPD participating in a pulmonary rehabilitation program.

Description

Inclusion Criteria:

• Male or female, at least 40 years of age;
• Diagnosis of Chronic Obstructive Pulmonary Disease (COPD);
• Enrolled in the study site's 12-week pulmonary rehabilitation program;
• Capable of completing a 6-minute walk test;
• Willing and able to comply with scheduled protocol procedures and follow up;
• Signed and dated informed consent and HIPAA materials indicating that the patient has agreed to participate in this study and has been informed of all pertinent aspects of the trial.

Exclusion Criteria:

• Patient has cognitive or physical limitations that, in the opinion of the investigator, limit the patient's ability to utilize the System as instructed;
• Patient is actively enrolled in another clinical investigation that, in the opinion of the investigator, interferes with or compromises either that patient's ability to participation in this study or the ability for the study to generate results;
• Patients who have implanted defibrillators or pacemakers;
• Patient is allergic to hydrocolloid adhesive;
• Patient does not speak English.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Utility	Correlation of reported health events with the multivariate change index	90 days

Collaborators and Investigators

• Sponsor: Karen Larimer
• Collaborators: Sunovian

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2019
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: March 14, 2019
• First Submitted That Met QC Criteria: March 15, 2019
• First Posted (Actual): March 18, 2019

Study Record Updates

• Last Update Posted (Actual): March 16, 2020
• Last Update Submitted That Met QC Criteria: March 12, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CTP-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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