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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: ICU Patients; Caregiver
• Intervention / Treatment: Other: Nurse-Led Educational Intervention for Caregivers of ICU Patients (Nurses For Family - N4F)

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; The control group receives standard care.
Experimental: Intervention group; An intervention group participating in the nurse-led educational intervention.	Other: Nurse-Led Educational Intervention for Caregivers of ICU Patients (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.; Other Names: Nurses For Family; N4F

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the time of enrollment in the study until 7 days after the intervention
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.	From the time of enrollment in the study until 7 days after the intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the beginning of the study and 7 days after receiving the intervention.
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).	At the beginning of the study and 7 days after receiving the intervention.

Collaborators and Investigators

• Sponsor: Medical University of Gdansk
• Collaborators: Université de Montréal

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: ICU; caregiver; Family-Centered Care; Nurse-Led Interventions
• Additional Relevant MeSH Terms: Health Care Facilities Workforce and Services; Health Personnel; Nurses
• Other Study ID Numbers: KB 18/26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No