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Pilot Evaluation of FAMCOPE-ICU (Family Coping and Emotion Regulation Tool in the ICU)

N/A
Waitlist Available
Led By Grant A Pignatiello, PhD, RN
Research Sponsored by University Hospitals Cleveland Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one week post-enrollment
Awards & highlights
No Placebo-Only Group

Summary

This trial involves a tablet-based tool called FAMCOPE-ICU designed to help people cope with the stress of having a loved one in the ICU. The tool offers resources and strategies to manage emotions and stress. It aims to provide support during a very challenging time.

Eligible Conditions
  • Coping Skills
  • Emotion Regulation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after dose 3, 5 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and after dose 3, 5 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability of Intervention Measure
Secondary study objectives
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
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: FAMCOPE-ICUExperimental Treatment1 Intervention
A digital eHealth emotion regulation and coping intervention.
Group II: Usual CareActive Control1 Intervention
The care and support routinely provided to SDMs of critically ill patients.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FAMCOPE-ICU
2022
N/A
~50

Find a Location

Who is running the clinical trial?

University Hospitals Cleveland Medical CenterLead Sponsor
327 Previous Clinical Trials
344,995 Total Patients Enrolled
Grant A Pignatiello, PhD, RNPrincipal InvestigatorCase Western Reserve University
Seth A Hoffer, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center
~15 spots leftby Dec 2025
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