Impact of Ibis on Patients With Advanced COPD

April 24, 2017 updated by: Senscio Systems

Impact of Ibis, a Digital Health Solution for Patient Activation and Early Intervention, on Acute Care Utilization by Patients With Advanced COPD

The purpose of this research is to determine if Ibis™, a digital therapeutics solution developed by Senscio Systems, reduces the emergency room visits and hospitalizations of patients with COPD.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Gold Stage II with a CAT Score above 19
  • Gold Stage III/IV with a CAT Score above 14

Exclusion Criteria:

  • Cognitive or physical impediments that inhibits patients from interacting with our digital therapeutics platform.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
EXPERIMENTAL: Digital Therapeutics
Patients assigned to the digital therapeutics arm will receive Ibis and all the associate services.
Behavioral: Digital Therapeutics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in Acute Care Utilization
Time Frame: 6 months and then again at 1 year
6 months and then again at 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Senscio Systems

Collaborators

Central Maine Medical Family

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ANTICIPATED)

January 1, 2018

Study Completion (ANTICIPATED)

January 1, 2018

Study Registration Dates

First Submitted

December 13, 2016

First Submitted That Met QC Criteria

April 24, 2017

First Posted (ACTUAL)

April 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Senscio-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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