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

Sponsor
Karen Larimer (Industry)
Overall Status
Terminated
CT.gov ID
NCT03879291
Collaborator
Sunovian (Other)
5
Enrollment
1
Location
11.7
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: pinpointIQ

Study Design

Study Type:
Observational
Actual Enrollment :
5 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Assessment of Utility of accelerateIQ in the Care of Patients Participating in a Pulmonary Rehabilitation Program
Actual Study Start Date :
Jan 9, 2019
Actual Primary Completion Date :
Dec 30, 2019
Actual Study Completion Date :
Dec 30, 2019

Outcome Measures

Primary Outcome Measures

  1. Clinical Utility [90 days]

    Correlation of reported health events with the multivariate change index

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 NorthShore University Health System Evanston Illinois United States 60201

Sponsors and Collaborators

  • Karen Larimer
  • Sunovian

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Karen Larimer, Director of Clinical Development, physIQ, Inc.
ClinicalTrials.gov Identifier:
NCT03879291
Other Study ID Numbers:
  • CTP-010
First Posted:
Mar 18, 2019
Last Update Posted:
Mar 16, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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

Study Results

No Results Posted as of Mar 16, 2020