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

NCT ID: NCT03879291

Last Updated: 2020-03-16

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-09
• Study Completion Date: 2019-12-30

Brief Summary

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.

Conditions

COPD; Pulmonary Rehabilitation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

pinpointIQ

The study will utilize physIQ's multivariate analytical methods that detect vital sign relationship changes compared to a patient's individual baseline. Changes in vital signs relationships may be indicative of current or future important clinical events. These changes are indicated through the Multivariate Change Index (MCI), which is a scalar index between 0 and 1, where values close to 0 indicate no significant change from baseline and values close to 1 indicated greater changes from baseline

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunovian

UNKNOWN

Sponsor Role: collaborator

Karen Larimer

INDUSTRY

Sponsor Role: lead

Responsible Party

Karen Larimer

Director of Clinical Development

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

NorthShore University Health System

Evanston, Illinois, United States

Countries

United States

Other Identifiers

CTP-010

Identifier Type: -

Identifier Source: org_study_id