Pilot Evaluation of FAMCOPE-ICU
Overview
- Phase
- Not Applicable
- Intervention
- FAMCOPE-ICU
- Conditions
- Emotion Regulation
- Sponsor
- University Hospitals Cleveland Medical Center
- Enrollment
- 49
- Locations
- 2
- Primary Endpoint
- Acceptability of Intervention Measure
- Status
- Completed
- Last Updated
- 9 days ago
Overview
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.
Investigators
Grant Pignatiello
Instructor and NCATS Clinical Research KL2 Scholar
University Hospitals Cleveland Medical Center
Eligibility Criteria
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
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 Exclusion Criteria
- •Not identified by critical care team as the LAR
- •Unable to speak or comprehend English
- •\< 18 years old
Arms & Interventions
FAMCOPE-ICU
A digital eHealth emotion regulation and coping intervention.
Intervention: FAMCOPE-ICU
Usual Care
The care and support routinely provided to SDMs of critically ill patients.
Outcomes
Primary Outcomes
Acceptability of Intervention Measure
Time Frame: After dose 3, 5 minutes
Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree)
Acceptability of Intervention Measure
Time Frame: After dose 1, 5 minutes
Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree)
Acceptability of Intervention Measure
Time Frame: After dose 2, 5 minutes
Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree)
Secondary Outcomes
- Change in Anxiety as Measured by PROMIS Anxiety Short Form(Baseline (enrollment), one week.)
- Change in Depression as Measured by PROMIS Depression Short Form(Baseline (enrollment), one week.)
- Sleep Disturbance as Measured by PROMIS Sleep Disturbance Short Form(Baseline (enrollment))
- Decision Fatigue Scale(One week post-enrollment)
- Decisional Conflict Scale(One week post-enrollment)
- Satisfaction as Measured by the Family Satisfaction in the Intensive Care Unit Scale - 24R(One week post-enrollment)