N/A N=49 Randomized Supportive Care

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

Emotion Regulation · Coping Skills

Bottom Line

View on ClinicalTrials.gov: NCT05408468 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcome: Primary: Acceptability of Intervention Measure — 4.36 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: FAMCOPE-ICU (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University Hospitals Cleveland Medical Center
Primary completion: Jul 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Acceptability of Intervention Measure	4.27	—
PRIMARY Acceptability of Intervention Measure	4.27	—
PRIMARY Acceptability of Intervention Measure	4.27	—
SECONDARY Change in Anxiety as Measured by PROMIS Anxiety Short Form	64.989; 61.30; 59.394; 57.518	0.387
SECONDARY Change in Depression as Measured by PROMIS Depression Short Form	56.896; 53.905	0.062
SECONDARY Sleep Disturbance as Measured by PROMIS Sleep Disturbance Short Form	60.63; 55.87	—
SECONDARY Decision Fatigue Scale	14.47; 11.88	0.369
SECONDARY Decisional Conflict Scale	7.89; 5.29	0.498
SECONDARY Satisfaction as Measured by the Family Satisfaction in the Intensive Care Unit Scale - 24R	—	—

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.

Eligibility Criteria

Patient Inclusion Criteria:

18-89 years old
Intensive Care Unit (ICU) length of stay (LOS) >= 48 hours
No anticipated ICU LOS for next 24 hours
Unable to make healthcare decisions

Family Inclusion Criteria

Identified by critical care team as legally authorized representative (LAR)
Able to speak or comprehend English
>= 18 years old

Patient Exclusion Criteria:

Less than 18 years or older than 89 years
ICU LOS < 48 hours
Anticipated ICU discharge within next 24 hours
Able to make healthcare decisions

Family Exclusion Criteria

Not identified by critical care team as the LAR
Unable to speak or comprehend English
< 18 years old

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05408468). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.