Nurse-Led Educational Intervention for Caregivers of ICU Patients (Nurses For Family - N4F)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Gdansk
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age >18 years
ICU stay > 24h
Age >18 years
consent to participate in the study
Disqualifiers
Age < 18 years
Discharged/Deceased form ICU < 24h
Age < 18 years
without cognitive impairment
Trial design
Design model
Parallel
Treatments tested in this trial
Nurse-Led Educational Intervention for Caregivers of ICU Patients (Nurses For Family - N4F)
Other interventionThe 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Control groupNo intervention 0 interventions
Group B: Intervention groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
From the time of enrollment in the study until 7 days after the intervention2
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.
Time frame
From the time of enrollment in the study until 7 days after the intervention.Secondary outcomes
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.
Time frame
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).
Time frame
At the beginning of the study and 7 days after receiving the intervention.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of Gdansk
Lead sponsor
Université de Montréal
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: