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Impact of Ibis on Patients With Advanced COPD

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ClinicalTrials.gov Identifier: NCT03131622
Recruitment Status : Unknown
Verified April 2017 by Senscio Systems.
Recruitment status was:  Enrolling by invitation
First Posted : April 27, 2017
Last Update Posted : April 27, 2017
Sponsor:
Collaborator:
Central Maine Medical Family
Information provided by (Responsible Party):
Senscio Systems

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
COPD Behavioral: Digital Therapeutics Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of Ibis, a Digital Health Solution for Patient Activation and Early Intervention, on Acute Care Utilization by Patients With Advanced COPD
Study Start Date : December 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Coal Tar

Arm Intervention/treatment
Experimental: Digital Therapeutics
Patients assigned to the digital therapeutics arm will receive Ibis and all the associate services.
Behavioral: Digital Therapeutics
No Intervention: Control



Primary Outcome Measures :
  1. Reduction in Acute Care Utilization [ Time Frame: 6 months and then again at 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
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Responsible Party: Senscio Systems
ClinicalTrials.gov Identifier: NCT03131622    
Other Study ID Numbers: Senscio-001
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Coal Tar
Keratolytic Agents
Dermatologic Agents