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Could a Nurse-Led support program ease Families' trauma after ICU?

NCT ID NCT05280691

Disease control Sponsor: Rahel Naef Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This trial tests whether a structured family support program helps relatives of critically ill patients in intensive care units (ICUs). The program includes a specialist nurse who supports families from admission through discharge and follow-up, plus better communication between the ICU team and family. Researchers will measure family satisfaction, communication quality, and mental health outcomes like anxiety and depression over 12 months. The goal is to see if this approach improves family well-being and can be used in other ICUs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Family Support Intervention (specialist nurse support and structured communication)
What this could lead to
If effective, this program could become a standard way to support families of ICU patients, reducing their risk of anxiety, depression, and PTSD.
What could go wrong
This is a relatively small, early-stage trial in only eight ICUs in Switzerland, so results may not apply to other hospitals or countries. The intervention may not improve outcomes enough to justify the extra resources.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

885 people

The number who actually took part.

Started

May 2022

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Potential participants are family members of critically ill persons admitted to a study ICU. A family member is defined as a close other from the patient's perspective, as noted in the clinical record or in advanced directives, or as indicated by the legally defined surrogate decision-maker. Inclusion criteria regarding patients (one or several): * Expected length of stay in ICU ≥48 hours, as predicted by the intaking ICU clinician (physician or nurse) at admission. * Life-threatening condition with a high risk of death or long-lasting functional impairment. * High risk of prolonged mechanical ventilation (\>24 hours). Inclusion criteria regarding family members (all must apply): * Primary support person of the patient. * Able to complete family-reported outcome measures (questionnaires) in German language. * Age ≥18 years. * Signed informed consent form. Exclusion criteria regarding patients (one leads to exclusion): * Preexisting declined general consent. * ICU stay \<24 hours. Exclusion criteria regarding family members (one leads to exclusion): * Prior inclusion in FICUS trial on another study ICU. * Cognitive inability to understand the study or complete the questionnaire as appraised by clinicians and / or study recruitment staff. * Inability to complete baseline data collection within the required timeframe after admission / study enrollment (Calvert et al., 2018).

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Conditions

The condition(s) this trial relates to.

anxiety disorder Depression post-traumatic stress disorder postintensive care syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depression, anxiety Family dynamics Family members Postintensive care syndrome Posttraumatic stress disorder Quality of life

Contacts and locations

Locations

  • Cantonal Hospital Baden

    Baden, Switzerland

  • Cantonal Hospital Graubünden

    Chur, Switzerland

  • Cantonal Hospital St. Gallen

    Sankt Gallen, Switzerland

  • Cantonal Hospital Winterthur

    Winterthur, Canton of Zurich, 8400, Switzerland

  • Hirslanden Clinic Zurich

    Zurich, Switzerland

  • Hospital Thun

    Thun, Switzerland

  • Lindenhof-Hospital

    Bern, Switzerland

  • Lucerne Cantonal Hospital

    Lucerne, Switzerland

  • Solothurn Hospitals AG, Cantonal Hospital Olten

    Olten, Switzerland

  • Spital Thurgau AG, Cantonal Hospital Frauenfeld

    Frauenfeld, Switzerland

  • University Hospital Bern - Inselspital

    Bern, Switzerland

  • University Hospital Zurich

    Zurich, 8091, Switzerland

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