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FAMCOPE-ICU for Emotion Regulation

N/A
Waitlist Available
Led By Seth A Hoffer, MD
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

Study Summary

This trial is testing whether using the FAMCOPE-ICU tool can help people cope better with stress when their loved one is in the ICU.

Eligible Conditions
  • Emotion Regulation
  • Coping Skills

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of Intervention Measure
Secondary outcome measures
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

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
318 Previous Clinical Trials
340,028 Total Patients Enrolled
Seth A Hoffer, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center
Grant A Pignatiello, PhD, RNPrincipal InvestigatorCase Western Reserve University
~18 spots leftby Jun 2025
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