Nurse-Led Educational Intervention for Caregivers of ICU Patients (Nurses For Family - N4F)
NCT07603219 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-05-22
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
Interventions
- 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.
Sponsors & Collaborators
-
Université de Montréal
collaborator OTHER -
Medical University of Gdansk
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-09-30
- Primary Completion
- 2027-05-31
- Completion
- 2027-09-30
More Related Trials
-
Improving Outcomes After PICU Admission: A Pilot Study
NCT01737021 ·Status: COMPLETED ·Phase: NA
-
Patient and Caregiver Psychological Functioning Following Neuro-ICU Admission: A Prospective Investigation
NCT02435641 ·Status: COMPLETED
-
ICU Patient and Family Comfort Study
NCT00798941 ·Status: COMPLETED ·Phase: NA
-
Patient- and Family-centred Care in the Adult Intensive Care Unit: a Feasibility Study
NCT06974214 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Nurses' Knowledge, Barriers and Practices in the Assessment of Delirium in the Intensive Care Unit
NCT05384964 ·Status: COMPLETED
-
Family Satisfaction (FS) in the Intensive Care Unit
NCT01449734 ·Status: COMPLETED
-
Enhancing Parent/Caregiver Engagement in the Pediatric Intensive Care Unit (PICU): A PICU Journal
NCT06117345 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
A Semi-structured Interview PACIENTE Improves Communication With Family Members at the Intensive Care Unit
NCT02336893 ·Status: COMPLETED ·Phase: NA
-
Structured Information During the Intensive Care Unit Stay
NCT00764933 ·Status: COMPLETED ·Phase: NA
-
The Family Cares Trial
NCT06984770 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Impact of Information Strategy Based on Booklet on Anxiety in Family in ICU
NCT01365377 ·Status: UNKNOWN ·Phase: NA
-
Tele-based Psychological Emotional Support for Informal CARegivers of COVID-19 Patients in Intensive Care
NCT04409821 ·Status: COMPLETED ·Phase: NA
-
The Family-ICU Trial
NCT06586541 ·Status: RECRUITING ·Phase: NA
-
Nurse Telephone Follow-up for Cardiovascular Patients
NCT07120841 ·Status: COMPLETED ·Phase: NA
-
Pilot Evaluation of FAMCOPE-ICU (Family Coping and Emotion Regulation Tool in the ICU)
NCT05408468 ·Status: COMPLETED ·Phase: NA
-
Psychological Group Intervention to Reduce Stress and Burnout Among Cardiac Intensive Care Nurses
NCT01412775 ·Status: UNKNOWN ·Phase: NA
-
The Caregiver Pathway - An Intervention to Support Caregivers of Critically Ill Patients
NCT04839406 ·Status: COMPLETED ·Phase: NA
-
Family Support Intervention in Intensive Care Units
NCT05280691 ·Status: COMPLETED ·Phase: NA
-
Pilot Feasibility Study of a Pragmatic Mixed-Methods Randomized Controlled Trial on a Follow-Up Bundle of Care for ICU Survivors and Caregivers
NCT06681649 ·Status: RECRUITING ·Phase: NA
-
Intensiva 2.0: Improve the Communication Towards Families of Critically Ill Patients
NCT03438175 ·Status: UNKNOWN ·Phase: NA
-
Developing and Testing a Nurse-Led Technology-Enhanced Family Engagement Program
NCT06128655 ·Status: COMPLETED ·Phase: NA
-
Simulation-based Education for Managing Stress in ICU Nurses
NCT02672072 ·Status: COMPLETED
-
Effectiveness of an Educational Intervention of Spirituality in Nursing Professionals Working in Critical Health Care Settings to Promote Spiritual Self-care.
NCT07092657 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
The Family Perspectives Project Pilot Trial
NCT06039501 ·Status: RECRUITING ·Phase: NA
-
Written Communication in the Intensive Care Unit
NCT05636371 ·Status: COMPLETED ·Phase: NA