Effectiveness of a Multimodal Intervention With Simulation for Learning Home Health Nursing Care of Patients With Multimorbidity and Heart Failure

NCT06855719 | Completed

• 1 other identifier: 087_2024
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the efficacy of a multimodal intervention with high-fidelity simulations on home health nursing in improving the care of multipathological patients with heart failure in nursing students. The main questions it aims to answer are:

• Does using validated simulation scenarios on multipathological patients with heart failure improve care competencies in nursing students?
• Does knowledge of scientific evidence and healthcare protocols improve nursing students' performance in the simulator? Researchers will compare a multimodal intervention with high-fidelity simulations on home health nursing to conventional intervention (theoretical teaching) to see if nursing students better learn competencies related to the care of patients with multimorbidity and heart failure during the home health nursing. Participants will:
• Experience simulations on validated simulation scenarios on multipathological patients with heart failure (All participants).
• Reflect on the intervention performed on the simulator through individual and group debriefings (Experimental Group).
• Learn about the main scientific evidence and international and national protocols related to comorbidities and health failure (Experimental Group).

Conditions

Multimorbidity; Heart Failure

Keywords

High Fidelity Simulation Training; Patient Simulation; Home Health Nursing; Primary Care Nursing; Family Nursing; Nursing Education Research; Students, Nursing; Education, Nursing

Outcome Measures

Primary Outcomes (2)

• Learning

  Learning will be analyzed through nursing students' performance during the simulations. Two independent observers with experience in tesching simulation will evaluate each simulation (pretest and posttest) through a validated checklist for each simulation scenario. The checklist evaluates the following aspects: (1) assessment of people and observation of the home (4 items), (2) nursing intervention (5 items), and (3) transversal competencies related to greeting, farewell, and communication skills (5 items). Each item will be evaluated by a dichotomous response (Yes/No) and a final overall evaluation (0-10 points). The observers' degree of agreement will be determined by Cohen's kappa.

  From enrollment to the end of intervention at 4 weeks.

• Empathy

  Empathy toward patients presenting with pluripathologies and heart failure is essential for providing professional care. The general measure of the students' empathy level was measured by the Spanish version of the Jefferson Scale of Empathy, student version (JSE-S), with a Cronbach's alpha coefficient of 0.90. The JSE-S is a 20-item instrument specifically developed to measure empathy in health profession education and patient care for administration to health profession students and practitioners. Items are answered on a 7-point Likert-type scale (1 = Strongly Disagree, 7 = Strongly Agree). Half of the items are positively worded and directly scored, and the other half are negatively worded (reverse scored). The total score are range from 20 to 140, where a higher score indicates greater empathy.

  From enrollment to the end of treatment at 4 weeks.

Secondary Outcomes (3)

• Self-confidence in learning

  From enrollment to the end of treatment at 5 weeks

• Quality of simulations

  From enrollment to the end of treatment at 5 weeks

• Satisfaction on simulations

  From enrollment to the end of treatment at 5 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

Students will receive simulation training, which will be evaluated through individual and group debriefing sessions. They will also have access to their recording simulations for autonomous learning. They will learn the protocols and current scientific evidence on the care of multipathologic patients with heart failure.

Other: Training in high-fidelity simulation and knowledge of care protocols in patients with multimorbidity and heart failure

Control Group

NO INTERVENTION

Students will receive only theoretical teaching about primary health care in nursing.

Interventions

Training in high-fidelity simulation and knowledge of care protocols in patients with multimorbidity and heart failure OTHER

Participants will perform an individual simulation as nurses related to the patient profile in their home (pretest and postest). After each simulation, each participant will receive a recording of their simulation, and both individual and group debriefings will be conducted. In addition, they will be trained in scientific evidence and international and national protocols regarding the care of these patients in the context of home health nursing.

Experimental Group

Eligibility Criteria

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

You may qualify if:

• Nursing students enrolled in the subject "Family and Community Nursing I".

You may not qualify if:

• Lack of attendance since the beginning of the course.
• Failure to follow the instructions of the instructors during the course of the study.
• Voluntary withdrawal from the study during the study or declaring non-participation.

Sponsors & Collaborators

• University of Cadiz: lead

Study Sites (1)

Faculty of Nursing

Algeciras, Cadiz, 11207, Spain

Location

Related Publications (17)

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MeSH Terms

Conditions

Heart Failure

Interventions

Multimorbidity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Comorbidity; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: To guarantee the objectivity and impartiality of the study, masking will be performed, which implies that the random assignment of the participants to the groups, the evaluation of the performance of the nursing students in the simulations in the pretest and posttest, and the subsequent statistical analysis of the data will be performed by researchers external to the study. Also, the evaluators of the simulations and the data analyst will not know the assignment of the participants to the Control and Experimental groups.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is a parallel group-randomized controlled trial.

Study Record Dates

• First Submitted: February 22, 2025
• First Posted: March 4, 2025
• Study Start: March 10, 2025
• Primary Completion: April 30, 2025
• Study Completion: May 23, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: * Study Protocol: February 2025 - March 2025. * SAP: March 2025 - December 2025. * ICF: March 2025 - December 2025. * Analytic Code: March 2025 - December 2025.
• Access Criteria: Researchers and anyone will be able to access the data through a public repository and supplementary material if the study is published in an academic journal.

Locations

ES (1)