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

University Hospitals Cleveland Medical Center49 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Emotion Regulation Coping Skills

Interventions

FAMCOPE-ICUBEHAVIORAL

(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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Acceptability of Intervention Measure

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

Time frame: 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)

Time frame: 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)

Time frame: After dose 3, 5 minutes

Secondary Outcomes

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".

Time frame: 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."

Time frame: Baseline (enrollment), one week.

Data from ClinicalTrials.gov

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