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Clinical Trial Summary

We hypothesized that engaging families in the care of critically ill patients could improve outcome both at the family and at the patient levels. Thus, the aim of this project is to assess the effects of a family engagement program on family members' satisfaction and on patients' well-being and quality of life.


Clinical Trial Description

Despite the health care professionals should consider the active involvement of families in Intensive Care Unit (ICU), little research investigating family member's contributions to care, including its outcomes on family itself and on patient care, has been rendered available. To assess the effects of a family engagement program on family members' satisfaction and on patients' well-being and quality of life. A quasi-experimental study with two non-randomized groups (94 per each group) will be performed in two general ICUs of an Academic Italian Hospital. The intervention will be carried out in a single ICU and consists of family members' involvement in the care of their beloved one with bed physical exercises and simple care tasks. Participants will be assessed for outcomes including the family satisfaction, assessed with the FS-ICU tool within 48 hours after the patient's discharge from ICU, the patient's sense of well-being, measured with a visual analogue scale within 30 minutes after the time period of a visit, and the quality of life, investigated with the SF-12 questionnaire within the first 48 hours after admission in ICU, at three and six months after ICU discharge by telephone. First, this study constitutes a significant step in a research agenda aimed at deepening the nursing sensitive outcomes in ICUs and the quality of hospital care. Secondly, result from this study may have the potential to better understand how families may modify patients' outcomes and whether the family members would benefit from an engagement program. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04311190
Study type Interventional
Source University of Udine
Contact Matteo Danielis
Phone +39 0432590923
Email matteo.danielis@uniud.it
Status Not yet recruiting
Phase N/A
Start date June 1, 2020
Completion date November 30, 2021

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