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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-15

Study Completion Date

2023-07-27

Brief Summary

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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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Detailed Description

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Conditions

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Emotion Regulation Coping Skills

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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FAMCOPE-ICU

A digital eHealth emotion regulation and coping intervention.

Group Type EXPERIMENTAL

FAMCOPE-ICU

Intervention Type 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

Usual Care

The care and support routinely provided to SDMs of critically ill patients.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* 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

* Not identified by critical care team as the LAR
* Unable to speak or comprehend English
* \< 18 years old

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes