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

Not Applicable

Completed

• Conditions: Emotion Regulation; Coping Skills
• Interventions: Behavioral: FAMCOPE-ICU

• Registration Number: NCT05408468
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-02
• Study First Submitted QC: 2022-06-02
• Study First Posted: 2022-06-07
• Study Start: 2022-08-15
• Primary Completion: 2023-07-27
• Study Completion: 2023-07-27
• Results First Submitted: 2024-11-29
• Status Verified: 2025-03
• Results First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Results First Posted: 2025-03-28
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FAMCOPE-ICU	FAMCOPE-ICU	A digital eHealth emotion regulation and coping intervention.

Primary Outcome Measures

Name	Time	Method
Acceptability of Intervention Measure	After dose 3, 5 minutes	Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree)

Secondary Outcome Measures

Name	Time	Method
Change in Anxiety as Measured by PROMIS Anxiety Short Form	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".
Change in Depression as Measured by PROMIS Depression Short Form	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."
Sleep Disturbance as Measured by PROMIS Sleep Disturbance Short Form	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."
Decision Fatigue Scale	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.
Decisional Conflict Scale	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)
Satisfaction as Measured by the Family Satisfaction in the Intensive Care Unit Scale - 24R	One week post-enrollment	Four item self-report survey; item responses range from 1 (Very dissatisfied) to 5 (Completely satisfied)

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States