Family Engagement in Intensive Care Unit

NCT04311190 | Unknown

• 1 other identifier: 3070
• Study Type: interventional
• Target: 188
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Critical Care; Intensive Care Unit; Nurse's Role; Family Members

Outcome Measures

Primary Outcomes (1)

• Family satisfaction (FS)

  FS-ICU tool

  Within 48 hours after the patient's discharge from ICU

Secondary Outcomes (2)

• Patient's sense of well-being

  30 minutes after the family involvement for the intervention group and in the same hours after the ICU visiting hours for the control group

• Quality of Life (QoL)

  At three and six months after ICU discharge

Study Arms (2)

ICU A

EXPERIMENTAL

Family members' involvement in the care of their beloved one

Other: Family engagement

ICU B

NO INTERVENTION

Standard care

Interventions

Family engagement OTHER

Physical exercises and simple care tasks

ICU A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PATIENT
• years of age and older;
• expected to stay in-ICU at least three days;
• with high or low acuity conditions.
• FAMILY MEMBER
• 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;
• of age or above;
• willing to visit the patient on a daily basis;
• willing to participate in the study.

You may not qualify if:

• PATIENT Patients' discharge from ICU, transfer to another hospital, or death.
• FAMILY MEMBER The unexpected suspension of visiting their loved ones in ICU daily

Sponsors & Collaborators

• University of Udine: lead

Study Officials

• Amato De Monte

  Department of Anestesia and Intensive Care (ASUFC) - UDINE, IT

  STUDY CHAIR

Central Study Contacts

Matteo Danielis

CONTACT

+39 0432590923; matteo.danielis@uniud.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 17, 2020
• Study Start: June 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: November 30, 2021
• Last Updated: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share