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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR002547 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FAMCOPE-ICU | Experimental | A digital eHealth emotion regulation and coping intervention. |
|
| Usual Care | No Intervention | The care and support routinely provided to SDMs of critically ill patients. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of Intervention Measure | Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree) | 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) | 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) | After dose 3, 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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". |
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Patient Inclusion Criteria:
Family Inclusion Criteria
Patient Exclusion Criteria:
Family Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Seth A Hoffer, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Grant A Pignatiello, PhD, RN | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Usual Care | The care and support routinely provided to SDMs of critically ill patients. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 The unit of participation was the legally authorized representative for an incapacitated patient. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acceptability of Intervention Measure | Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree) | Usual care participants did not complete the intervention so no data was collected on them for acceptability of the intervention. | Posted | Mean | Standard Deviation | units on a scale | After dose 1, 5 minutes |
|
One week post enrollment
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Grant Pignatiello | University Hospitals Cleveland Medical Center | 216-368-4480 | gap54@case.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 11, 2022 | Nov 25, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 4, 2023 | Apr 8, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000080103 | Emotional Regulation |
| D000068356 | Self-Control |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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|
| 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." | Baseline (enrollment), one week. |
| 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." | Baseline (enrollment) |
| 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. | One week post-enrollment |
| 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) | One week post-enrollment |
| 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) | One week post-enrollment |
| Overwhelmed by clinical situation |
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| Personal illness precluding participation |
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| Withdrawn due to death patient death (unrelated to LAR participation in trial) |
|
| BG001 | Usual Care | The care and support routinely provided to SDMs of critically ill patients. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | Usual Care | The care and support routinely provided to SDMs of critically ill patients. |
|
|
| Primary | Acceptability of Intervention Measure | Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree) | Usual care participants did not complete the intervention so no data was collected on them for acceptability of the intervention. | Posted | Mean | Standard Deviation | units on a scale | After dose 2, 5 minutes |
|
|
|
| Primary | Acceptability of Intervention Measure | Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree) | Usual care participants did not complete the intervention so no data was collected on them for acceptability of the intervention. | Posted | Mean | Standard Deviation | units on a scale | After dose 3, 5 minutes |
|
|
|
| Secondary | 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". | Posted | Least Squares Mean | 95% Confidence Interval | T score | Baseline (enrollment), one week. |
|
|
|
|
| Secondary | 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." | Posted | Least Squares Mean | 95% Confidence Interval | T Score | Baseline (enrollment), one week. |
|
|
|
|
| Secondary | 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." | Posted | Mean | Standard Deviation | T-Score | Baseline (enrollment) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Raw score | One week post-enrollment |
|
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | Raw score | One week post-enrollment |
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|
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| Secondary | 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) | 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. | Posted | One week post-enrollment |
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Usual Care | The care and support routinely provided to SDMs of critically ill patients. | 0 | 20 | 0 | 20 | 0 | 20 |
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| 0.387 |
| Mean Difference (Net) |
| -3.782 |
| Standard Error of the Mean |
| 2.048 |
| 2-Sided |
Baseline 2.048 One week 2.122 |
| Superiority |
| 0.062 |
| Mean Difference (Net) |
| -0.764 |
| Standard Error of the Mean |
| 2.003 |
| 2-Sided |
Baseline 2.003 One week 2.069 |
| Superiority |