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CaregiverN4FNCT07603219

Nurse-Led Educational Intervention for Caregivers of ICU Patients (Nurses For Family - N4F)

A study testing Nurse-Led Educational Intervention for Caregivers of ICU Patients (Nurses For Family - N4F) in people with Caregiver and ICU Patients, run by Medical University of Gdansk.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Admission of a loved one to the intensive care unit (ICU) is a highly stressful experience for family members and caregivers. Many caregivers report increased levels of anxiety, stress, and depressive symptoms, often due to uncertainty about the patient's condition and difficulties in understanding medical… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Caregiver, ICU Patients
What is being tested?
Nurse-Led Educational Intervention for Caregivers of ICU Patients (Nurses For Family - N4F)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
Sep 2026to Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients:
  • Age >18 years
  • ICU stay > 24h
  • Caregivers:
  • Age >18 years
  • consent to participate in the study
  • meeting the definition of a caregiver
  • able to complete questionnaires

Who cannot join

  • Patients:
  • Age < 18 years
  • Discharged/Deceased form ICU < 24h
  • Caregivers:
  • Age < 18 years
  • without cognitive impairment
  • no consent to participate in the study
  • No able to complete questionnaires

About this study

Official title: Feasibility And Acceptability of a Nurse-Led Educational Intervention for Caregivers of ICU Patients (Nurses For Family - N4F): Pilot Study

Admission of a loved one to the intensive care unit (ICU) is a highly stressful experience for family members and caregivers. Many caregivers report increased levels of anxiety, stress, and depressive symptoms, often due to uncertainty about the patient's condition and difficulties in understanding medical information. Improving communication and providing clear, structured information may help reduce this psychological burden.

This study aims to evaluate the feasibility, acceptability, and preliminary effectiveness of a nurse-led educational intervention called "Nurses for Family" (N4F), designed to support caregivers of ICU patients.

Read more

The study will include adult caregivers (aged 18 years or older) of patients admitted to the ICU for more than 24 hours. Participants must provide informed consent and be able to complete questionnaires independently. A total of 20 participants will be enrolled and allocated to one of two groups: an intervention group (receiving nurse-led educational support) or a control group (receiving standard care).

Data will be collected at two time points during the ICU stay. At baseline (24-48 hours after ICU admission), participants will complete the Hospital Anxiety and Depression Scale (HADS), which measures symptoms of anxiety and depression. At follow-up (7 days later), participants will complete the HADS again, along with the Family Satisfaction in the ICU (FSICU-24) questionnaire. Feasibility will be assessed based on recruitment and retention rates, adherence to the study protocol, and completeness of data collection. Acceptability will be evaluated through interviews conducted with participants from the control group.

This pilot study is expected to determine whether the N4F intervention is feasible and acceptable in a clinical setting and to provide preliminary evidence regarding its potential to reduce psychological distress and improve satisfaction among caregivers of ICU patients.

Read the detailed description

Aim: This study was designed to investigate the feasibility, acceptability, and preliminary efficacy of a nurse-led educational intervention for caregivers of ICU patients (Nurses for Family - N4F).

Design: This pilot study will use a single-center, prospective, non-randomized, quasi-experimental design.

Method: Caregivers of adult patients hospitalized in the ICU for more than 24 hours will be included in the study. Participants will be persons aged ≥18 years who meet the definition of a caregiver, provide informed consent to participate in the study, and are able to complete the questionnaires independently. Caregivers under the age of 18, with cognitive impairments, who do not consent to participate in the study, or who are unable to complete the questionnaires will be excluded from the study. Participants will be allocated either to the intervention group and receive the nurse-led educational intervention or to the control group and receive usual care. The acceptability of the intervention will be assessed based on interviews with participants in the control group, and feasibility will be evaluated according to criteria including recruitment, retention, protocol adherence, and data completeness (≥80% recruitment and completion rates, ≥90% protocol adherence, ≤15% missing data). Data will be collected at two time points during the patient's ICU stay. At T1 (24-48 hours after admission), participants will complete the Hospital Anxiety and Depression Scale (HADS), a validated questionnaire measuring psychological distress. At T2 (7 days after the intervention), participants will complete both the HADS and the FSICU-24 questionnaire. The data collection procedure will include standardized methods, such as clinical information, questionnaires, and interviews with patients' families (control group), in accordance with the study protocol. A sample of 20 caregivers was selected for the study: 10 in the intervention group and 10 in the control group. This sample size was selected based on pilot study literature and is considered adequate to report feasibility, acceptability, and preliminary efficacy.

Results: The pilot study is expected to confirm the feasibility and acceptability of a nurse-led educational intervention for caregivers of intensive care unit patients. Preliminary effects regarding the reduction of symptoms of anxiety and depression among caregivers and increased caregiver satisfaction will also be explored.

Being tested
Nurse-Led Educational Intervention for Caregivers of ICU Patients (Nurses For Family - N4F)
Keywords
ICU, caregiver, Family-Centered Care, Nurse-Led Interventions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nurse-Led Educational Intervention for Caregivers of ICU Patients (Nurses For Family - N4F)Other

    Also called Nurses For Family, N4F

    The intervention was designed as a two-stage process: a theoretical component and a practical component:

    (I) The intervention begins by providing families with an informational brochure titled "Guide to the Intensive Care Unit." This initial step aims to reduce uncertainty and anxiety by setting clear expectations regarding the stay in the ICU. The theoretical part will be delivered by an experienced ICU nurse, a specialist in intensive care, in person in a designated room to ensure a comfortable environment for the family.

    (II) After distributing the brochure, the ICU nurse conducts an educational session at the patient's bedside. During this session, families receive explanations about the equipment in the intensive care unit, monitoring devices, and the patient care process. The final component of the intervention is a support brochure for families titled "How You Can Help a Loved One".This brochure contains practical guidance on supporting the patient.

Study groups in NCT07603219
Study groupRoleWhat they receive
Control groupNo interventionThe control group receives standard care.
Intervention groupExperimentalAn intervention group participating in the nurse-led educational intervention.
Receives: Other: Nurse-Led Educational Intervention for Caregivers of ICU Patients (Nurses For Family - N4F)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility measured by session completion and dropout rate differences between groups

    Feasibility will be measured based on the actual number of training sessions conducted for the intervention groups compared to the planned number, and the difference in the dropout rate between the intervention and control groups.

    Measured: From the time of enrollment in the study until 7 days after the intervention

  2. Acceptability of the intervention sssessed via semi-structured individual interviews.

    The acceptability of the intervention will be assessed in this pilot study using a qualitative method involving semi-structured individual interviews.

    Measured: From the time of enrollment in the study until 7 days after the intervention.

Secondary outcomes (2)

  1. Change from baseline to day 7 in Anxiety, Depression

    Preliminary effectiveness will be assessed at the beginning of the study and 7 days after receiving the intervention using (a) the Hospital Anxiety and Depression Scale (HADS-M).

    The Hospital Anxiety and Depression Scale (HADS) by A.S. Zigmond and R.P. Snaith, Polish version developed by Majkowicz M. et al. This is a screening method used to identify symptoms of anxiety and depression, consisting of 7 items examining symptoms of depression and 7 items relating to anxiety. For both scales, a score between 0 and 7 points indicates no disorder; between 8 and 10 points indicate borderline conditions, and scores between 11 and 21 points indicate a disorder.

    Measured: At the beginning of the study and 7 days after receiving the intervention.

  2. Change from baseline to day 7 in Family Satisfaction Scores.

    Preliminary effectiveness will be assessed at the beginning of the study and 7 days after receiving the intervention using The Family Satisfaction in the Intensive Care Unit (FSICU-24).

    The questionnaire contains 24 questions that assess two main areas: satisfaction with patient care (15 items) - includes, among other things, an assessment of staff competence, care, availability, communication, and responsiveness to patient needs, and satisfaction with the decision-making process (9 items) - assesses, among other things, the quality of information provided to the family, emotional support, the opportunity to ask questions, and participation in treatment decisions. Each item is assessed using a Likert scale (usually 5-point), where a higher score indicates a higher level of satisfaction. The results converted to a scale of 0 to 100 points, according to the author's original key (0 = very dissatisfied, 100 = completely satisfied).

    Measured: At the beginning of the study and 7 days after receiving the intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

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
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
A sample of 20 participants was selected for the study: 10 in the intervention group and 10 in the control group. This sample size is in line with the recommendations of Thabane et al., who indicate that 10-20 participants per group is sufficient to assess key aspects of feasibility in trials.
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07603219
Sponsor's protocol ID
KB 18/26
Acronym
N4F
Status last verified
May 2026
First submitted
12 May 2026
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Satysfakcja rodziny z opieki na oddziale Anestezjologii i Intensywnej Terapii: FS-ICU 24R© 2019. https://www.fsicu.ca/professionals/survey/versions/

  • De Walden-Gałuszko K, Majkowicz M. Praktyczna ocena efektywności opieki paliatywnej -wybrane techniki badawcze. Skala HADS-M (zmodyfikowana skala HAD). w: Ocena jakości opieki paliatywnej w teorii i praktyce. 2000.

  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

    PubMed 6880820

  • Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017 Jan 26;17(1):88. doi: 10.1186/s12913-017-2031-8.

    PubMed 28126032

  • Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664.

    PubMed 34812790

  • Szczeklik W, Fronczek J, Włudarczyk A, Fronczek M. Przewodnik po oddziale intensywnej terapii. Broszura informacyjna dla rodzin i bliskich hospitalizowanych pacjentów

  • Mailhot T, Cossette S, Lavoie P, Maheu-Cadotte MA, Fontaine G, Bourbonnais A, Cote J. The development of the MENTOR_D nursing intervention: Supporting family involvement in delirium management. Int J Older People Nurs. 2022 Sep;17(5):e12462. doi: 10.1111/opn.12462. Epub 2022 Apr 10.

    PubMed 35403357

  • Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.

    PubMed 20053272

Questions about this trial

What is this clinical trial studying?

A study testing Nurse-Led Educational Intervention for Caregivers of ICU Patients (Nurses For Family - N4F) in people with Caregiver and ICU Patients, run by Medical University of Gdansk.

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 8 inclusion and 8 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: opening soon, as of the sponsor's last update on 22 May 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility measured by session completion and dropout rate differences between groups (time frame: From the time of enrollment in the study until 7 days after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07603219, which also lists 8 linked publications.

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 22 May 2026.

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