Barriers to Use of Remote Monitoring in Patients With Implantable Cardioverter Defibrillators
Sponsor
Yale University (Other)
Overall Status
Completed
CT.gov ID
NCT02361333
Collaborator
(none)
20
1
2
24
0.8
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Barriers to Use of Remote Monitoring in Patients With Implantable Cardioverter Defibrillators
Study Start Date
:
Oct 1, 2012
Actual Primary Completion Date
:
Apr 1, 2014
Actual Study Completion Date
:
Oct 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Teaching Intervention Patients will be taught how to install and use a remote monitor. |
Behavioral: Teaching Intervention
Patients will be taught how to install and use a remote monitor
|
| No Intervention: No Intervention Patients will not be taught how to install and use a remote monitor |
Outcome Measures
Primary Outcome Measures
- Number of remote Transmissions of data using remote monitor made by patient [6 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yale Electrophysiology | New Haven | Connecticut | United States | 06511 |
Sponsors and Collaborators
- Yale University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT02361333
Other Study ID Numbers:
- 1208010730
First Posted:
Feb 11, 2015
Last Update Posted:
Jan 17, 2018
Last Verified:
Jan 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No