Coping Skills, Emotion Regulation
Conditions
Keywords
Critical Care, Informal Caregiving, Surrogate Decision-Making, Self-Regulation
Brief summary
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.
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
Sponsors
University Hospitals Cleveland Medical Center
National Center for Advancing Translational Sciences (NCATS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Intervention Measure | After dose 1, 5 minutes | Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety as Measured by PROMIS Anxiety Short Form | 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". |
| Change in Depression as Measured by PROMIS Depression Short Form | 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." |
| Sleep Disturbance as Measured by PROMIS Sleep Disturbance Short Form | 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." |
| Decision Fatigue Scale | 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. |
| Decisional Conflict Scale | 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) |
| Satisfaction as Measured by the Family Satisfaction in the Intensive Care Unit Scale - 24R | One week post-enrollment | Four item self-report survey; item responses range from 1 (Very dissatisfied) to 5 (Completely satisfied) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSeth A Hoffer, MD
University Hospitals Cleveland Medical Center
PRINCIPAL_INVESTIGATORGrant A Pignatiello, PhD, RN
Case Western Reserve University
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| Usual Care The care and support routinely provided to SDMs of critically ill patients. | 20 |
| Total | 48 |
Baseline characteristics
| Characteristic | Usual Care | Total | FAMCOPE-ICU |
|---|---|---|---|
| Age, Continuous | 59.20 years STANDARD_DEVIATION 12.64 | 58.54 years STANDARD_DEVIATION 13.23 | 58.07 years STANDARD_DEVIATION 13.84 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 47 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 41 Participants | 25 Participants |
| Sex: Female, Male Female | 16 Participants | 36 Participants | 20 Participants |
| Sex: Female, Male Male | 4 Participants | 12 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 20 |
| other Total, other adverse events | 0 / 29 | 0 / 20 |
| serious Total, serious adverse events | 0 / 29 | 0 / 20 |
Outcome results
Primary
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
Population: Usual care participants did not complete the intervention so no data was collected on them for acceptability of the intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FAMCOPE-ICU | Acceptability of Intervention Measure | 4.36 units on a scale | Standard Deviation 0.7 |
Primary
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
Population: Usual care participants did not complete the intervention so no data was collected on them for acceptability of the intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FAMCOPE-ICU | Acceptability of Intervention Measure | 4.37 units on a scale | Standard Deviation 0.69 |
Primary
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
Population: Usual care participants did not complete the intervention so no data was collected on them for acceptability of the intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FAMCOPE-ICU | Acceptability of Intervention Measure | 4.27 units on a scale | Standard Deviation 1 |
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.
Time frame: Baseline (enrollment), one week.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| FAMCOPE-ICU | Change in Anxiety as Measured by PROMIS Anxiety Short Form | Baseline | 64.989 T score |
| FAMCOPE-ICU | Change in Anxiety as Measured by PROMIS Anxiety Short Form | One week | 59.394 T score |
| Usual Care | Change in Anxiety as Measured by PROMIS Anxiety Short Form | Baseline | 61.30 T score |
| Usual Care | Change in Anxiety as Measured by PROMIS Anxiety Short Form | One week | 57.518 T score |
p-value: 0.387Mixed Models Analysis
p-value: 0.387Mixed Models Analysis
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.
Time frame: Baseline (enrollment), one week.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| FAMCOPE-ICU | Change in Depression as Measured by PROMIS Depression Short Form | 56.896 T Score |
| Usual Care | Change in Depression as Measured by PROMIS Depression Short Form | 53.905 T Score |
p-value: 0.062Mixed Models Analysis
p-value: 0.062Mixed Models Analysis
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)
Time frame: One week post-enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FAMCOPE-ICU | Decisional Conflict Scale | 7.89 Raw score | Standard Deviation 13.98 |
| Usual Care | Decisional Conflict Scale | 5.29 Raw score | Standard Deviation 7.39 |
p-value: 0.498t-test, 2 sided
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.
Time frame: One week post-enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FAMCOPE-ICU | Decision Fatigue Scale | 14.47 Raw score | Standard Deviation 10.08 |
| Usual Care | Decision Fatigue Scale | 11.88 Raw score | Standard Deviation 5.98 |
p-value: 0.369t-test, 2 sided
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)
Time frame: 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.
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.
Time frame: Baseline (enrollment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FAMCOPE-ICU | Sleep Disturbance as Measured by PROMIS Sleep Disturbance Short Form | 60.63 T-Score | Standard Deviation 8.72 |
| Usual Care | Sleep Disturbance as Measured by PROMIS Sleep Disturbance Short Form | 55.87 T-Score | Standard Deviation 8.88 |