N/A
Completed N=49
Pilot Evaluation of FAMCOPE-ICU (Family Coping and Emotion Regulation Tool in the ICU)
Emotion Regulation · Coping Skills
Source: ClinicalTrials.gov NCT05408468 ↗
Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Acceptability of Intervention Measure — 4.36 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptability of Intervention Measure |
4.27 | — |
| SECONDARY Change in Anxiety as Measured by PROMIS Anxiety Short Form |
64.989; 61.30; 59.394; 57.518 | 0.387 |
| SECONDARY Change in Depression as Measured by PROMIS Depression Short Form |
56.896; 53.905 | 0.062 |
| SECONDARY Sleep Disturbance as Measured by PROMIS Sleep Disturbance Short Form |
60.63; 55.87 | — |
| SECONDARY Decision Fatigue Scale |
14.47; 11.88 | 0.369 |
| SECONDARY Decisional Conflict Scale |
7.89; 5.29 | 0.498 |
| SECONDARY Satisfaction as Measured by the Family Satisfaction in the Intensive Care Unit Scale - 24R |
— | — |
Eligibility 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 Exclusion Criteria
- Not identified by critical care team as the LAR
- Unable to speak or comprehend English
- < 18 years old
Data sourced from ClinicalTrials.gov (NCT05408468). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.