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

Browse trials for

• Emotional Regulation 545
• Self-Control 168

Keywords

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

Emotional Regulation

545 studies on the registry are indexed under Emotional Regulation; 188 are open to participants now.

This study's enrollment of 49 is below the median of 79 across 498 interventional studies indexed under Emotional Regulation.

Lead sponsor

University Hospitals Cleveland Medical Center is the lead sponsor of 295 studies on the registry; 45 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 30 (83%) have results posted.

Eligibility criteria

Study arms

• Experimental
  FAMCOPE-ICU

  A digital eHealth emotion regulation and coping intervention.

  Behavioral: FAMCOPE-ICU

• No intervention
  Usual Care

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

Interventions

• BehavioralFAMCOPE-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

Primary outcomes

1. 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

2. 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

3. 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

1. 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.

2. 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.

3. 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."

   Time frame: Baseline (enrollment)

4. 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.

   Time frame: One week post-enrollment

5. 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)

   Time frame: One week post-enrollment

6. 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)

   Time frame: One week post-enrollment

Baseline characteristics

Study documents

• Protocol and statistical analysis plan ↗ · Jan 11, 2022
• Informed consent form ↗ · Apr 4, 2023

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No