Pilot Evaluation of FAMCOPE-ICU (Family Coping and Emotion Regulation Tool in the ICU)

Emotion Regulation Clinical Trial

Official title:

Pilot Evaluation of FAMCOPE-ICU

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05408468
• Other study ID #: STUDY20220055
• Status: Completed
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: July 27, 2023

Study information

• Verified date: July 2023
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: July 27, 2023
• Est. primary completion date: July 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Coping Skills
• Emotion Regulation

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Secondary	Change in Anxiety as measured by PROMIS Anxiety Short Form	Four item self-report survey; item responses range from 1 (Never) to 5 (Always)	Baseline (enrollment), one week.
Secondary	Change in Depression as measured by PROMIS Depression Short Form	Four item self-report survey; item responses range from 1 (Never) to 5 (Always)	Baseline (enrollment), one week.
Secondary	Change in Sleep Disturbance as measured by PROMIS Sleep Disturbance Short Form	Eight item self-report survey; item responses range from 1 (Not at all) to 5 (Very much)	Baseline (enrollment), one week.
Secondary	Decision Fatigue Scale	Nine item self-report survey; item responses range from 0 (Strongly Disagree) to 3 (Strongly Agree)	One week post-enrollment
Secondary	Decisional Conflict Scale	10 item self-report survey; item responses are "yes", "unsure", and "no".	One week post-enrollment
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)	One week post-enrollment