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

University Hospitals (UH) logo

University Hospitals (UH)

Status

Completed

Conditions

Coping Skills
Emotion Regulation

Treatments

Behavioral: FAMCOPE-ICU

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05408468
STUDY20220055
KL2TR002547 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

49 patients

Sex

All

Ages

18 to 89 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

49 participants in 2 patient groups

FAMCOPE-ICU
Experimental group
Description:
A digital eHealth emotion regulation and coping intervention.
Treatment:
Behavioral: FAMCOPE-ICU
Usual Care
No Intervention group
Description:
The care and support routinely provided to SDMs of critically ill patients.

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Grant A Pignatiello, PhD, RN

Data sourced from clinicaltrials.gov

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