GAME-EOL for Implantable Cardioverter Defibrillator (ICD) User

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Implantable Cardioverter Defibrillator (ICD) User+1 MoreGAME-EOL - Behavioral
Eligibility
18 - 99
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test if the "Hello Game" can help people with heart devices talk about end-of-life matters with their families.

Eligible Conditions
  • Implantable Cardioverter Defibrillator (ICD) User
  • End-Stage Disease

Treatment Effectiveness

Study Objectives

6 Primary · 0 Secondary · Reporting Duration: At study completion, up to 3 months post intervention

8 weeks post intervention
Completion of Advance Directives
Month 3
Feasibility of GAME-EOL
Baseline, post intervention
Change in attitudes about discussions and actions related to end of life
Change in concordance of end of life (EOL) Attitudes
Change in experience of end of life issues
Knowledge about the ICD in relation to end of life (EOL).

Trial Safety

Trial Design

2 Treatment Groups

Usual care recipients
1 of 2
Usual care plus GAME-EOL intervention
1 of 2

Active Control

Experimental Treatment

120 Total Participants · 2 Treatment Groups

Primary Treatment: GAME-EOL · No Placebo Group · N/A

Usual care plus GAME-EOL intervention
Behavioral
Experimental Group · 1 Intervention: GAME-EOL · Intervention Types: Behavioral
Usual care recipientsNoIntervention Group · 1 Intervention: Usual care recipients · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at study completion, up to 3 months post intervention

Who is running the clinical trial?

University of Kentucky CCTSUNKNOWN
Jennifer MillerLead Sponsor
Jennifer Miller, PhD4.942 ReviewsPrincipal Investigator - University of Kentucky
Medical School - University of Puerto Rico School of Medicine, Doctor of Medicine
Universidad de Puerto Rico, Residency in Obstetrics and Gynecology
5Patient Review
She was lovely, professional, and managed to put me at ease immediately. I'll definitely be returning.

Eligibility Criteria

Age 18 - 99 · All Participants · 2 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
Kentucky100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Kentucky100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References