Barriers to Use of Remote Monitoring in Patients With Imp... | NCT02361333

Studies
Barriers to Use of Remote Monitoring in Patients With Implantable Cardioverter Defibrillators

NCT02361333

Sponsor

Yale University

Status

Completed

Last Update Posted

Jan 17, 2018Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Cardiac Patients
Implantable Cardioverter Defibrillator

Interventions

Teaching Intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Apr 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Jan 20, 2015

First Submission Date that Met QC Criteria

Feb 10, 2015

First Posted Date

Feb 11, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2018

Last Update Posted Date

Jan 17, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether a teaching intervention can help increase the use of remote monitors in patients with implantable cardioverter defibrillators.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Teaching Intervention	Experimental	Patients will be taught how to install and use a remote monitor.	Behavioral: Teaching Intervention
No Intervention	No Intervention	Patients will not be taught how to install and use a remote monitor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Teaching Intervention	Behavioral	Patients will be taught how to install and use a remote monitor	Teaching Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of remote Transmissions of data using remote monitor made by patient		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Received a Medtronic implantable cardioverter defibrillator (ICD) at Yale Electrophysiology, between January 2007 and June 2012
ICD is compatible with Carelink, Medtronic's remote monitoring system

Exclusion Criteria:

Less than 18 years of age
From a vulnerable population
Incompetent/suffers from dementia
Non-English speaking

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yale Electrophysiology		New Haven	Connecticut	06511	United States