NCT02361333

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 11, 2015

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

1.5 years

First QC Date

January 20, 2015

Last Update Submit

January 12, 2018

Conditions

Cardiac PatientsImplantable Cardioverter Defibrillator

Outcome Measures

Primary Outcomes (1)

  • Number of remote Transmissions of data using remote monitor made by patient

    6 months

Study Arms (2)

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

Teaching InterventionBEHAVIORAL

Patients will be taught how to install and use a remote monitor

Teaching Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Electrophysiology

New Haven, Connecticut, 06511, United States

Location

Study Design

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

Study Record Dates

First Submitted

January 20, 2015

First Posted

February 11, 2015

Study Start

October 1, 2012

Primary Completion

April 1, 2014

Study Completion

October 1, 2014

Last Updated

January 17, 2018

Record last verified: 2018-01

Locations

US(1)