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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ after dose 3, 5 minutes

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University Hospitals Cleveland Medical CenterLead Sponsor

317 Previous Clinical Trials

340,208 Total Patients Enrolled

Seth A Hoffer, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center

Grant A Pignatiello, PhD, RNPrincipal InvestigatorCase Western Reserve University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment extend to individuals over 45 years of age?

"This clinical trial will only accept participants aged 18 to 89. Specialized studies are available for those under 18, while 27 trials have been designed specifically for individuals over the age of 65."

Answered by AI

Is recruitment still open for this medical trial?

"This clinical trial, which was initially published on August 15th 2022 and updated five days later, is currently seeking participants."

Answered by AI

Do I meet the requirements for participation in this experiment?

"This clinical trial seeks 120 individuals between 18 and 89 who have difficulty controlling their emotional responses. In order to be considered, applicants must meet the following requirements: 48 hours or more in an Intensive Care Unit (ICU), not expected to receive further ICU care within 24 hours, lack of autonomy when it comes to medical decisions, a family member with similar criteria as listed above, legally authorised representative for healthcare decision-making if needed, English language fluency and being over 18 years old."

Answered by AI

What is the aggregate participant count for this medical experiment?

"Affirmative, clinicaltrials.gov attests that the trial is still recruiting participants since its inception on August 15th 2022 and latest update occurring five days later. 120 volunteers are sought from a single site for this research endeavor."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Grant Pignatiello 2022. "Pilot Evaluation of FAMCOPE-ICU (Family Coping and Emotion Regulation Tool in the ICU)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05408468.