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

Pilot Evaluation of FAMCOPE-ICU

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.

Study Overview

• Status: Completed
• Conditions: Coping Skills; Emotion Regulation
• Intervention / Treatment: Behavioral: FAMCOPE-ICU

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FAMCOPE-ICU; A digital eHealth emotion regulation and coping intervention.	Behavioral: FAMCOPE-ICU; (1) FAMCOPE-ICU is a digital eHealth emotion regulation and coping intervention. FAMCOPE-ICU contains three digital modules representing the three interventional doses. Corresponding with Gross's Extended Process Model of Emotion Regulation, the three respective doses entail assessments, adaptive feedback, and interactive activities pertaining to understanding their affective experiences, learning strategies to regulate emotions and stress, and practicing these skills in a virtual decision-making task. Each dose of the intervention is expected to last 10-15 minutes
No Intervention: Usual Care; The care and support routinely provided to SDMs of critically ill patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Intervention Measure	Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree)	After dose 1, 5 minutes
Acceptability of Intervention Measure	Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree)	After dose 2, 5 minutes
Acceptability of Intervention Measure	Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree)	After dose 3, 5 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Seth A Hoffer, MD, University Hospitals Cleveland Medical Center; Principal Investigator: Grant A Pignatiello, PhD, RN, Case Western Reserve University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Actual): July 27, 2023
• Study Completion (Actual): July 27, 2023

Study Registration Dates

• First Submitted: June 2, 2022
• First Submitted That Met QC Criteria: June 2, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Self-Regulation; Critical Care; Informal Caregiving; Surrogate Decision-Making
• Additional Relevant MeSH Terms: Behavior; Social Behavior; Self-Control; Emotional Regulation
• Other Study ID Numbers: STUDY20220055; KL2TR002547 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No