Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-01 @ 7:29 AM
Study NCT ID:
NCT05408468
Status:
COMPLETED
Last Update Posted:
2025-03-28
First Post:
2022-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot Evaluation of FAMCOPE-ICU (Family Coping and Emotion Regulation Tool in the ICU)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080103', 'term': 'Emotional Regulation'}, {'id': 'D000068356', 'term': 'Self-Control'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gap54@case.edu', 'phone': '216-368-4480', 'title': 'Dr. Grant Pignatiello', 'organization': 'University Hospitals Cleveland Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'One week post enrollment', 'description': 'Death was collected as a data point only for the ICU patients related to the LARs. No LARs died from participating in this study. Patient deaths were related to the clinical trajectory and were unrelated to family participation in this study. 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.', 'eventGroups': [{'id': 'EG000', 'title': 'FAMCOPE-ICU', 'description': "A digital eHealth emotion regulation and coping intervention.\n\nFAMCOPE-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", 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'The care and support routinely provided to SDMs of critically ill patients.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Acceptability of Intervention Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FAMCOPE-ICU', 'description': "A digital eHealth emotion regulation and coping intervention.\n\nFAMCOPE-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"}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'The care and support routinely provided to SDMs of critically ill patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.36', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After dose 1, 5 minutes', 'description': 'Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Usual care participants did not complete the intervention so no data was collected on them for acceptability of the intervention.'}, {'type': 'PRIMARY', 'title': 'Acceptability of Intervention Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FAMCOPE-ICU', 'description': "A digital eHealth emotion regulation and coping intervention.\n\nFAMCOPE-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"}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'The care and support routinely provided to SDMs of critically ill patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.37', 'spread': '0.69', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After dose 2, 5 minutes', 'description': 'Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Usual care participants did not complete the intervention so no data was collected on them for acceptability of the intervention.'}, {'type': 'PRIMARY', 'title': 'Acceptability of Intervention Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FAMCOPE-ICU', 'description': "A digital eHealth emotion regulation and coping intervention.\n\nFAMCOPE-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"}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'The care and support routinely provided to SDMs of critically ill patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.27', 'spread': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After dose 3, 5 minutes', 'description': 'Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Usual care participants did not complete the intervention so no data was collected on them for acceptability of the intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Anxiety as Measured by PROMIS Anxiety Short Form', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FAMCOPE-ICU', 'description': "A digital eHealth emotion regulation and coping intervention.\n\nFAMCOPE-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"}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'The care and support routinely provided to SDMs of critically ill patients.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '64.989', 'groupId': 'OG000', 'lowerLimit': '61.521', 'upperLimit': '68.457'}, {'value': '61.30', 'groupId': 'OG001', 'lowerLimit': '57.197', 'upperLimit': '64.403'}]}]}, {'title': 'One week', 'categories': [{'measurements': [{'value': '59.394', 'groupId': 'OG000', 'lowerLimit': '55.616', 'upperLimit': '63.172'}, {'value': '57.518', 'groupId': 'OG001', 'lowerLimit': '53.275', 'upperLimit': '61.761'}]}]}], 'analyses': [{'pValue': '0.387', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-5.595', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.731', 'estimateComment': 'Baseline 1.731 One week 1.894', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.387', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-3.782', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.048', 'estimateComment': 'Baseline 2.048 One week 2.122', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (enrollment), one week.', 'description': '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.\n\nInterpretation: 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".', 'unitOfMeasure': 'T score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Depression as Measured by PROMIS Depression Short Form', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FAMCOPE-ICU', 'description': "A digital eHealth emotion regulation and coping intervention.\n\nFAMCOPE-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"}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'The care and support routinely provided to SDMs of critically ill patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.896', 'groupId': 'OG000', 'lowerLimit': '53.504', 'upperLimit': '60.288'}, {'value': '53.905', 'groupId': 'OG001', 'lowerLimit': '49.892', 'upperLimit': '57.918'}]}]}], 'analyses': [{'pValue': '0.062', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-4.50', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.693', 'estimateComment': 'Baseline 1.693 One week 1.840', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.062', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.764', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.003', 'estimateComment': 'Baseline 2.003 One week 2.069', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (enrollment), one week.', 'description': '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.\n\nInterpretation: 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."', 'unitOfMeasure': 'T Score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sleep Disturbance as Measured by PROMIS Sleep Disturbance Short Form', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FAMCOPE-ICU', 'description': "A digital eHealth emotion regulation and coping intervention.\n\nFAMCOPE-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"}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'The care and support routinely provided to SDMs of critically ill patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.63', 'spread': '8.72', 'groupId': 'OG000'}, {'value': '55.87', 'spread': '8.88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (enrollment)', 'description': '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.\n\nInterpretation: 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."', 'unitOfMeasure': 'T-Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Decision Fatigue Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FAMCOPE-ICU', 'description': "A digital eHealth emotion regulation and coping intervention.\n\nFAMCOPE-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"}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'The care and support routinely provided to SDMs of critically ill patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.47', 'spread': '10.08', 'groupId': 'OG000'}, {'value': '11.88', 'spread': '5.98', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.369', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.58', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.84', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'One week post-enrollment', 'description': '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.', 'unitOfMeasure': 'Raw score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Decisional Conflict Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FAMCOPE-ICU', 'description': "A digital eHealth emotion regulation and coping intervention.\n\nFAMCOPE-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"}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'The care and support routinely provided to SDMs of critically ill patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.89', 'spread': '13.98', 'groupId': 'OG000'}, {'value': '5.29', 'spread': '7.39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.498', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.59', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.79', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'One week post-enrollment', 'description': '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)', 'unitOfMeasure': 'Raw score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Satisfaction as Measured by the Family Satisfaction in the Intensive Care Unit Scale - 24R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FAMCOPE-ICU', 'description': "A digital eHealth emotion regulation and coping intervention.\n\nFAMCOPE-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"}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'The care and support routinely provided to SDMs of critically ill patients.'}], 'timeFrame': 'One week post-enrollment', 'description': 'Four item self-report survey; item responses range from 1 (Very dissatisfied) to 5 (Completely satisfied)', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FAMCOPE-ICU', 'description': "A digital eHealth emotion regulation and coping intervention.\n\nFAMCOPE-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"}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'The care and support routinely provided to SDMs of critically ill patients.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Overwhelmed by clinical situation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Personal illness precluding participation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawn due to death patient death (unrelated to LAR participation in trial)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'One participant withdrew from study after providing written informed consent, but before baseline data collection.\n\nThe unit of participation was the legally authorized representative for an incapacitated patient.\n\nIncapacitated patients were not considered enrolled, because our inclusion criteria explicitly required patients to lack capacity to provide consent.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'FAMCOPE-ICU', 'description': "A digital eHealth emotion regulation and coping intervention.\n\nFAMCOPE-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\n\nThe unit of participation was the legally authorized representative for an incapacitated patient."}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'The care and support routinely provided to SDMs of critically ill patients.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.07', 'spread': '13.84', 'groupId': 'BG000'}, {'value': '59.20', 'spread': '12.64', 'groupId': 'BG001'}, {'value': '58.54', 'spread': '13.23', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-11', 'size': 714620, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-25T10:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2022-06-02', 'resultsFirstSubmitDate': '2024-11-29', 'studyFirstSubmitQcDate': '2022-06-02', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-11', 'studyFirstPostDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability of Intervention Measure', 'timeFrame': 'After dose 1, 5 minutes', 'description': 'Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree)'}, {'measure': 'Acceptability of Intervention Measure', 'timeFrame': 'After dose 2, 5 minutes', 'description': 'Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree)'}, {'measure': 'Acceptability of Intervention Measure', 'timeFrame': 'After dose 3, 5 minutes', 'description': 'Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree)'}], 'secondaryOutcomes': [{'measure': 'Change in Anxiety as Measured by PROMIS Anxiety Short Form', 'timeFrame': 'Baseline (enrollment), one week.', 'description': '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.\n\nInterpretation: 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".'}, {'measure': 'Change in Depression as Measured by PROMIS Depression Short Form', 'timeFrame': 'Baseline (enrollment), one week.', 'description': '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.\n\nInterpretation: 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."'}, {'measure': 'Sleep Disturbance as Measured by PROMIS Sleep Disturbance Short Form', 'timeFrame': 'Baseline (enrollment)', 'description': '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.\n\nInterpretation: 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."'}, {'measure': 'Decision Fatigue Scale', 'timeFrame': 'One week post-enrollment', 'description': '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.'}, {'measure': 'Decisional Conflict Scale', 'timeFrame': 'One week post-enrollment', 'description': '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)'}, {'measure': 'Satisfaction as Measured by the Family Satisfaction in the Intensive Care Unit Scale - 24R', 'timeFrame': 'One week post-enrollment', 'description': 'Four item self-report survey; item responses range from 1 (Very dissatisfied) to 5 (Completely satisfied)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Critical Care', 'Informal Caregiving', 'Surrogate Decision-Making', 'Self-Regulation'], 'conditions': ['Emotion Regulation', 'Coping Skills']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Patient Inclusion Criteria:\n\n* 18-89 years old\n* Intensive Care Unit (ICU) length of stay (LOS) \\>= 48 hours\n* No anticipated ICU LOS for next 24 hours\n* Unable to make healthcare decisions\n\nFamily Inclusion Criteria\n\n* Identified by critical care team as legally authorized representative (LAR)\n* Able to speak or comprehend English\n* \\>= 18 years old\n\nPatient Exclusion Criteria:\n\n* Less than 18 years or older than 89 years\n* ICU LOS \\< 48 hours\n* Anticipated ICU discharge within next 24 hours\n* Able to make healthcare decisions\n\nFamily Exclusion Criteria\n\n* Not identified by critical care team as the LAR\n* Unable to speak or comprehend English\n* \\< 18 years old'}, 'identificationModule': {'nctId': 'NCT05408468', 'briefTitle': 'Pilot Evaluation of FAMCOPE-ICU (Family Coping and Emotion Regulation Tool in the ICU)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'Pilot Evaluation of FAMCOPE-ICU', 'orgStudyIdInfo': {'id': 'STUDY20220055'}, 'secondaryIdInfos': [{'id': 'KL2TR002547', 'link': 'https://reporter.nih.gov/quickSearch/KL2TR002547', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FAMCOPE-ICU', 'description': 'A digital eHealth emotion regulation and coping intervention.', 'interventionNames': ['Behavioral: FAMCOPE-ICU']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'The care and support routinely provided to SDMs of critically ill patients.'}], 'interventions': [{'name': 'FAMCOPE-ICU', 'type': 'BEHAVIORAL', 'description': "(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", 'armGroupLabels': ['FAMCOPE-ICU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Seth A Hoffer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}, {'name': 'Grant A Pignatiello, PhD, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Case Western Reserve University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instructor and NCATS Clinical Research KL2 Scholar', 'investigatorFullName': 'Grant Pignatiello', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}