Critical CareFENICENCT04311190
Family Engagement in Intensive Care Unit
A study testing Family engagement in people with Critical Care and Intensive Care Unit, run by University of Udine.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Intensive Care Unit, Nurse's Role
- What is being tested?
- Family engagement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PATIENT
- 18 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;
Show all 9Show fewer
- 18 of age or above;
- willing to visit the patient on a daily basis;
- willing to participate in the study.
Who cannot join
- PATIENT Patients' discharge from ICU, transfer to another hospital, or death.
- FAMILY MEMBER The unexpected suspension of visiting their loved ones in ICU daily
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Family ENgagement in Intensive Care Environments (FENICE): a Quasi-experimental Study
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.
Read the 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.
- Conditions
- Critical Care, Intensive Care Unit, Nurse's Role, Family Members
- Being tested
- Family engagement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family engagementOther
Physical exercises and simple care tasks
| Study group | Role | What they receive |
|---|---|---|
| ICU A | Experimental | Family members' involvement in the care of their beloved one Receives: Other: Family engagement |
| ICU B | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family satisfaction (FS)
FS-ICU tool
Measured: Within 48 hours after the patient's discharge from ICU
Secondary outcomes (2)
Patient's sense of well-being
Visual analogue scale
Measured: 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)
SF-12
Measured: At three and six months after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 Jun 2020 (estimated)
- Primary completion1 May 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Udine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amato De Monte, Study chair, Department of Anestesia and Intensive Care (ASUFC) - UDINE, IT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311190
- Sponsor's protocol ID
- 3070
- Acronym
- FENICE
- Status last verified
- Mar 2020
- First submitted
- 13 Mar 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family ENgagement in Intensive Care Environments (FENICE): a Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT04311190
- Acronym / sponsor ID
- FENICE / 3070
- Conditions
- Critical Care, Intensive Care Unit, Nurse's Role, Family Members
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- University of UdineUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICU A | Experimental | Other: Family engagementFamily members' involvement in the care of their beloved one |
| ICU B | No intervention | –Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- PATIENT
- 18 years of age and older;
- expected to stay in-ICU at least three days;
- with high or low acuity conditions.
- FAMILY MEMBER
Key exclusion criteria (2 listed)
- PATIENT Patients' discharge from ICU, transfer to another hospital, or death.
- FAMILY MEMBER The unexpected suspension of visiting their loved ones in ICU daily
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family engagementPhysical exercises and simple care tasks | Other | ICU A |
Primary outcome
Family satisfaction (FS)
Time frame: Within 48 hours after the patient's discharge from ICU
FS-ICU tool
2 secondary outcomes
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
Quality of Life (QoL)
Time frame: At three and six months after ICU discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amato De Monte study chair
Department of Anestesia and Intensive Care (ASUFC) - UDINE, IT
Questions about this trial
What is this clinical trial studying?
A study testing Family engagement in people with Critical Care and Intensive Care Unit, run by University of Udine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matteo Danielis (+39 0432590923, matteo.danielis@uniud.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family satisfaction (FS) (time frame: Within 48 hours after the patient's discharge from ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.