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Completed

NCT Number: NCT05408468

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

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Key information

Conditions

Emotion Regulation Behavior Coping Skills Emotional Regulation Self-Control Social Behavior

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Acceptability of Intervention Measure

    Time frame: After dose 1, 5 minutes

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

  2. Acceptability of Intervention Measure

    Time frame: After dose 2, 5 minutes

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

  3. Acceptability of Intervention Measure

    Time frame: After dose 3, 5 minutes

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

Secondary outcomes

  1. Change in Anxiety as Measured by PROMIS Anxiety Short Form

    Time frame: 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".

  2. Change in Depression as Measured by PROMIS Depression Short Form

    Time frame: 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."

  3. Sleep Disturbance as Measured by PROMIS Sleep Disturbance Short Form

    Time frame: 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."

  4. Decision Fatigue Scale

    Time frame: 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.

  5. Decisional Conflict Scale

    Time frame: 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)

  6. Satisfaction as Measured by the Family Satisfaction in the Intensive Care Unit Scale - 24R

    Time frame: One week post-enrollment

    Four item self-report survey; item responses range from 1 (Very dissatisfied) to 5 (Completely satisfied)

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

Pilot Evaluation of FAMCOPE-ICU

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 7, 2022
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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