FAMCOPE-ICU for Emotion Regulation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University Hospitals Cleveland Medical Center, Cleveland, OH
Emotion Regulation+1 More
FAMCOPE-ICU - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Having a family member or loved one in the ICU can be a very stressful experience. The investigators have created a tablet-based tool (FAMCOPE-ICU) that is designed to help people in this position cope with this experience.

Eligible Conditions

  • Emotion Regulation
  • Skills, Coping

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Baseline (enrollment), one week.

After dose 3, 5 minutes
Acceptability of Intervention Measure
Baseline (enrollment), one week.
Change in Anxiety as measured by PROMIS Anxiety Short Form
Change in Depression as measured by PROMIS Depression Short Form
Change in Sleep Disturbance as measured by PROMIS Sleep Disturbance Short Form
One week post-enrollment
Decision Fatigue Scale
Decisional Conflict Scale
Satisfaction as measured by the Family Satisfaction in the Intensive Care Unit Scale - 24R

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Usual Care
1 of 2
FAMCOPE-ICU
1 of 2
Active Control
Experimental Treatment

120 Total Participants · 2 Treatment Groups

Primary Treatment: FAMCOPE-ICU · No Placebo Group · N/A

FAMCOPE-ICU
Behavioral
Experimental Group · 1 Intervention: FAMCOPE-ICU · Intervention Types: Behavioral
Usual CareNoIntervention Group · 1 Intervention: Usual Care · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (enrollment), one week.

Trial Background

Grant Pignatiello, Instructor and NCATS Clinical Research KL2 Scholar
Principal Investigator
University Hospitals Cleveland Medical Center
Closest Location: University Hospitals Cleveland Medical Center · Cleveland, OH
Photo of university hospitals cleveland medical center  1Photo of university hospitals cleveland medical center  2Photo of university hospitals cleveland medical center  3
2011First Recorded Clinical Trial
1 TrialsResearching Emotion Regulation
172 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are identified as a legally authorized representative (LAR) by the critical care team.
You are 18 years old or older.
You are a patient.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.