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

NCT07603219 | Not Yet Recruiting

• 1 other identifier: KB 18/26
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Caregiver; ICU Patients

Keywords

ICU; caregiver; Family-Centered Care; Nurse-Led Interventions

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change from baseline to day 7 in Anxiety, Depression

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

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

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

Study Arms (2)

Control group

NO INTERVENTION

The control group receives standard care.

Intervention group

EXPERIMENTAL

An intervention group participating in the nurse-led educational intervention.

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

Interventions

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.

Also known as: Nurses For Family, N4F

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Gdansk: lead
• Université de Montréal: collaborator

Related Publications (8)

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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 6880820 BACKGROUND

• 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.

  PMID: 28126032 BACKGROUND

• 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.

  PMID: 34812790 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 35403357 BACKGROUND

• 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.

  PMID: 20053272 BACKGROUND

MeSH Terms

Interventions

Nurses

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share