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Family Engagement in Intensive Care Unit (FENICE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04311190
Recruitment Status : Not yet recruiting
First Posted : March 17, 2020
Last Update Posted : March 17, 2020
Information provided by (Responsible Party):
University of Udine

Brief 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.

Condition or disease Intervention/treatment Phase
Critical Care Intensive Care Unit Nurse's Role Family Members Other: Family engagement Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Family ENgagement in Intensive Care Environments (FENICE): a Quasi-experimental Study
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Family Issues

Arm Intervention/treatment
Experimental: ICU A
Family members' involvement in the care of their beloved one
Other: Family engagement
Physical exercises and simple care tasks

No Intervention: ICU B
Standard care

Primary Outcome Measures :
  1. Family satisfaction (FS) [ Time Frame: Within 48 hours after the patient's discharge from ICU ]
    FS-ICU tool

Secondary Outcome Measures :
  1. Patient's sense of well-being [ Time Frame: 30 minutes after the family involvement for the intervention group and in the same hours after the ICU visiting hours for the control group ]
    Visual analogue scale

  2. Quality of Life (QoL) [ Time Frame: At three and six months after ICU discharge ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:


  • 18 years of age and older;
  • expected to stay in-ICU at least three days;
  • with high or low acuity conditions.


  • being the patient's spouse, or in a blood relation, or next of kin, and/or with whom the patient spends most of the time;
  • 18 of age or above;
  • willing to visit the patient on a daily basis;
  • willing to participate in the study.

Exclusion Criteria:

PATIENT Patients' discharge from ICU, transfer to another hospital, or death.

FAMILY MEMBER The unexpected suspension of visiting their loved ones in ICU daily

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04311190

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Contact: Matteo Danielis +39 0432590923

Sponsors and Collaborators
University of Udine
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Study Chair: Amato De Monte Department of Anestesia and Intensive Care (ASUFC) - UDINE, IT
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Responsible Party: University of Udine Identifier: NCT04311190    
Other Study ID Numbers: 3070
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No