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

NCT05408468 | Completed Results

• 2 other identifiers: STUDY20220055KL2TR002547
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotion Regulation; Coping Skills

Keywords

Critical Care; Informal Caregiving; Surrogate Decision-Making; Self-Regulation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Change in Anxiety as Measured by PROMIS Anxiety Short Form

  Baseline (enrollment), one week.

• Change in Depression as Measured by PROMIS Depression Short Form

  Baseline (enrollment), one week.

• Sleep Disturbance as Measured by PROMIS Sleep Disturbance Short Form

  Baseline (enrollment)

• Decision Fatigue Scale

  One week post-enrollment

• Decisional Conflict Scale

  One week post-enrollment

Study Arms (2)

FAMCOPE-ICU

EXPERIMENTAL

A digital eHealth emotion regulation and coping intervention.

Behavioral: FAMCOPE-ICU

Usual Care

NO INTERVENTION

The care and support routinely provided to SDMs of critically ill patients.

Interventions

FAMCOPE-ICU BEHAVIORAL

(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

FAMCOPE-ICU

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Emotional Regulation; Self-Control

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Results Point of Contact

• Title: Dr. Grant Pignatiello
• Organization: University Hospitals Cleveland Medical Center

gap54@case.edu

216-368-4480

Study Officials

• Seth A Hoffer, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

• Grant A Pignatiello, PhD, RN

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 7, 2022
• Study Start: August 15, 2022
• Primary Completion: July 27, 2023
• Study Completion: July 27, 2023
• Last Updated: April 23, 2026
• Results First Posted: March 28, 2025

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)