NCT05408468

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

Completed NA Results posted Last updated 28 March 2025

What this trial tests

NA trial testing FAMCOPE-ICU in Emotion Regulation in 49 participants. Completed in 27 July 2023.

Timeline

15 August 2022

Primary endpoint
27 July 2023

27 July 2023

Quick facts

Lead sponsor	University Hospitals Cleveland Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	49
Start date	15 August 2022
Primary completion	27 July 2023
Estimated completion	27 July 2023
Sites	1 location across United States

Drugs / interventions tested

• FAMCOPE-ICU

Conditions studied

• Emotion Regulation — all drugs for Emotion Regulation →
• Coping Skills — all drugs for Coping Skills →

Sponsor

University Hospitals Cleveland Medical Center

Who can join

Adults 18 to 89, any sex, with Emotion Regulation or Coping Skills. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Acceptability of Intervention Measure Primary · After dose 1, 5 minutes

Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree)

Group	Value	95% CI
FAMCOPE-ICU	4.36	± 0.7

Acceptability of Intervention Measure Primary · After dose 2, 5 minutes

Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree)

Group	Value	95% CI
FAMCOPE-ICU	4.37	± 0.69

Acceptability of Intervention Measure Primary · After dose 3, 5 minutes

Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree)

Group	Value	95% CI
FAMCOPE-ICU	4.27	± 1

Change in Anxiety as Measured by PROMIS Anxiety Short Form Secondary · Baseline (enrollment), one week.

Name: PROMIS Item Bank v1.0-Emotional Distress-Anxiety - Short Form 4a Scoring: The four items' responses (ranging from 1 (Never) to 5 (Always) are summed to form a raw score. The raw scores are converted to a T-Score (mean = 50; Standard deviation = 10) derived from a general population. Interpretation: Higher scores indicate a greater severity in anxiety. Scores less than 55 are "within normal limits", 55-60 are "mild", 60-70 are "moderate", and greater than 70 are "severe".

Baseline

Group	Value	95% CI
FAMCOPE-ICU	64.989	61.521 – 68.457
Usual Care	61.30	57.197 – 64.403

One week

Group	Value	95% CI
FAMCOPE-ICU	59.394	55.616 – 63.172
Usual Care	57.518	53.275 – 61.761

Change in Depression as Measured by PROMIS Depression Short Form Secondary · Baseline (enrollment), one week.

Name: PROMIS Item Bank v1.0-Emotional Distress-Depression - Short Form 4a Scoring: The four items' responses (ranging from 1 (Never) to 5 (Always) are summed to form a raw score. The raw scores are converted to a T-Score (mean = 50; Standard deviation = 10) derived from a general population. Interpretation: Higher scores indicate greater severity in depression. Scores less than 55 are "within normal limits," 55-60 are "mild," 60-70 are "moderate," and greater than 70 are "severe."

Group	Value	95% CI
FAMCOPE-ICU	56.896	53.504 – 60.288
Usual Care	53.905	49.892 – 57.918

Sleep Disturbance as Measured by PROMIS Sleep Disturbance Short Form Secondary · Baseline (enrollment)

Name: PROMIS Item Bank v1.0 - Sleep Disturbance - Short Form 8b Scoring: The eight items' responses (ranging from 1 (Never) to 5 (Always) are summed to form a raw score. The raw scores are converted to a T-Score (mean = 50; Standard deviation = 10) derived from a general population. Interpretation: Higher scores indicate greater severity in anxiety. Scores less than 55 are "within normal limits," 55-60 are "mild," 60-70 are "moderate," and greater than 70 are "severe."

Group	Value	95% CI
FAMCOPE-ICU	60.63	± 8.72
Usual Care	55.87	± 8.88

Decision Fatigue Scale Secondary · One week post-enrollment

Nine item self-report survey; item responses range from 0 (Strongly Disagree) to 3 (Strongly Agree). Item are summed to form a raw score (range 0-27), with higher scores indicated higher decision fatigue.

Group	Value	95% CI
FAMCOPE-ICU	14.47	± 10.08
Usual Care	11.88	± 5.98

Decisional Conflict Scale Secondary · One week post-enrollment

10 item self-report survey; item responses are "yes" (0), "unsure" (2), and "no" (4). Items are summed, divided by 10, multiplied by 25. Scores range from 0 (no decisional conflict) to 100 (high decisional conflict)

Group	Value	95% CI
FAMCOPE-ICU	7.89	± 13.98
Usual Care	5.29	± 7.39

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.