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NCT Number: NCT07603219

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

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.

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.

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Key information

Conditions

Caregiver ICU Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Other

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.

Other names: Nurses For Family, N4F

Primary outcomes

  1. 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

    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.

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

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

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

Secondary outcomes

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

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

    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.

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

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

    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).

Sponsors and collaborators

Lead sponsor

Medical University of Gdansk

Other

Collaborators

  • Université de Montréal

Registry information

Official study title

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

Acronym: N4F

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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