NCT03131622

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 27, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

1.1 years

First QC Date

December 13, 2016

Last Update Submit

April 24, 2017

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

  • Reduction in Acute Care Utilization

    6 months and then again at 1 year

Study Arms (2)

Digital Therapeutics

EXPERIMENTAL

Patients assigned to the digital therapeutics arm will receive Ibis and all the associate services.

Behavioral: Digital Therapeutics

Control

NO INTERVENTION

Interventions

Digital TherapeuticsBEHAVIORAL
Digital Therapeutics

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2016

First Posted

April 27, 2017

Study Start

December 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

April 27, 2017

Record last verified: 2017-04