Trial Outcomes & Findings for Pilot Evaluation of FAMCOPE-ICU (Family Coping and Emotion Regulation Tool in the ICU) (NCT NCT05408468)

NCT ID: NCT05408468

Last Updated: 2025-03-28

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 49 participants
• Primary outcome timeframe: After dose 2, 5 minutes
• Results posted on: 2025-03-28

Participant Flow

One participant withdrew from study after providing written informed consent, but before baseline data collection. The unit of participation was the legally authorized representative for an incapacitated patient. Incapacitated patients were not considered enrolled, because our inclusion criteria explicitly required patients to lack capacity to provide consent.

Participant milestones

Measure	FAMCOPE-ICU A digital eHealth emotion regulation and coping intervention. 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	Usual Care The care and support routinely provided to SDMs of critically ill patients.
Overall Study STARTED	29	20
Overall Study COMPLETED	19	17
Overall Study NOT COMPLETED	10	3

Reasons for withdrawal

Measure	FAMCOPE-ICU A digital eHealth emotion regulation and coping intervention. 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	Usual Care The care and support routinely provided to SDMs of critically ill patients.
Overall Study Lost to Follow-up	3	1
Overall Study Physician Decision	1	0
Overall Study Overwhelmed by clinical situation	3	0
Overall Study Personal illness precluding participation	1	0
Overall Study Withdrawn due to death patient death (unrelated to LAR participation in trial)	2	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	FAMCOPE-ICU n=28 Participants A digital eHealth emotion regulation and coping intervention. 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 The unit of participation was the legally authorized representative for an incapacitated patient.	Usual Care n=20 Participants The care and support routinely provided to SDMs of critically ill patients.	Total n=48 Participants Total of all reporting groups
Age, Continuous	58.07 years STANDARD_DEVIATION 13.84 • n=5 Participants	59.20 years STANDARD_DEVIATION 12.64 • n=7 Participants	58.54 years STANDARD_DEVIATION 13.23 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	16 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	20 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	16 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: After dose 1, 5 minutes

Population: Usual care participants did not complete the intervention so no data was collected on them for acceptability of the intervention.

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

Outcome measures

Measure	FAMCOPE-ICU n=24 Participants A digital eHealth emotion regulation and coping intervention. 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	Usual Care The care and support routinely provided to SDMs of critically ill patients.
Acceptability of Intervention Measure	4.36 units on a scale Standard Deviation 0.7	—

PRIMARY outcome

Timeframe: After dose 2, 5 minutes

Population: Usual care participants did not complete the intervention so no data was collected on them for acceptability of the intervention.

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

Outcome measures

Measure	FAMCOPE-ICU n=24 Participants A digital eHealth emotion regulation and coping intervention. 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	Usual Care The care and support routinely provided to SDMs of critically ill patients.
Acceptability of Intervention Measure	4.37 units on a scale Standard Deviation 0.69	—

PRIMARY outcome

Timeframe: After dose 3, 5 minutes

Population: Usual care participants did not complete the intervention so no data was collected on them for acceptability of the intervention.

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

Outcome measures

Measure	FAMCOPE-ICU n=19 Participants A digital eHealth emotion regulation and coping intervention. 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	Usual Care The care and support routinely provided to SDMs of critically ill patients.
Acceptability of Intervention Measure	4.27 units on a scale Standard Deviation 1	—

SECONDARY outcome

Timeframe: 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".

Outcome measures

Measure	FAMCOPE-ICU n=28 Participants A digital eHealth emotion regulation and coping intervention. 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	Usual Care n=20 Participants The care and support routinely provided to SDMs of critically ill patients.
Change in Anxiety as Measured by PROMIS Anxiety Short Form One week	59.394 T score Interval 55.616 to 63.172	57.518 T score Interval 53.275 to 61.761
Change in Anxiety as Measured by PROMIS Anxiety Short Form Baseline	64.989 T score Interval 61.521 to 68.457	61.30 T score Interval 57.197 to 64.403

SECONDARY outcome

Timeframe: 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."

Outcome measures

Measure	FAMCOPE-ICU n=28 Participants A digital eHealth emotion regulation and coping intervention. 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	Usual Care n=20 Participants The care and support routinely provided to SDMs of critically ill patients.
Change in Depression as Measured by PROMIS Depression Short Form	56.896 T Score Interval 53.504 to 60.288	53.905 T Score Interval 49.892 to 57.918

SECONDARY outcome

Timeframe: 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."

Outcome measures

Measure	FAMCOPE-ICU n=28 Participants A digital eHealth emotion regulation and coping intervention. 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	Usual Care n=20 Participants The care and support routinely provided to SDMs of critically ill patients.
Sleep Disturbance as Measured by PROMIS Sleep Disturbance Short Form	60.63 T-Score Standard Deviation 8.72	55.87 T-Score Standard Deviation 8.88

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	FAMCOPE-ICU n=17 Participants A digital eHealth emotion regulation and coping intervention. 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	Usual Care n=17 Participants The care and support routinely provided to SDMs of critically ill patients.
Decision Fatigue Scale	14.47 Raw score Standard Deviation 10.08	11.88 Raw score Standard Deviation 5.98

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	FAMCOPE-ICU n=19 Participants A digital eHealth emotion regulation and coping intervention. 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	Usual Care n=17 Participants The care and support routinely provided to SDMs of critically ill patients.
Decisional Conflict Scale	7.89 Raw score Standard Deviation 13.98	5.29 Raw score Standard Deviation 7.39

SECONDARY outcome

Timeframe: One week post-enrollment

Population: Data not collected, Investigator was concerned about participant burden and ended up not collecting this data. This is a pilot study and this outcome measure was determined to not be worth the participants time.

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

Outcome measures

Outcome data not reported

Adverse Events

FAMCOPE-ICU

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Grant Pignatiello

University Hospitals Cleveland Medical Center

Phone: 216-368-4480

Email: gap54@case.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place