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

June 30, 2025 updated by: Antonio Jesús Marín Paz, University of Cadiz

Effectiveness of a Multimodal Intervention With Simulation for Learning Home Health Nursing Care of Patients With Multimorbidity and Heart Failure: A Randomized Controlled Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Cadiz
      • Algeciras, Cadiz, Spain, 11207
        • Faculty of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
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
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.
No Intervention: Control Group
Students will receive only theoretical teaching about primary health care in nursing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Learning
Time Frame: From enrollment to the end of intervention at 4 weeks.
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
Time Frame: From enrollment to the end of treatment at 4 weeks.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-confidence in learning
Time Frame: From enrollment to the end of treatment at 5 weeks
Immediately after the simulation was performed. This will be measured using the Student Satisfaction and Self-Confidence in Learning (SCLS) scale. The scale is based on a five-point Likert scale, ranging from "strongly disagree" to "strongly agree." The scores that can be obtained range from 13 to 65 points and were validated with a Cronbach's alpha of 0.90.
From enrollment to the end of treatment at 5 weeks
Quality of simulations
Time Frame: From enrollment to the end of treatment at 5 weeks
After the individual and group debriefings. The Educational Practices Questionnaire (student version) (EPQ) will be used. It consists of 16 items, assessed on two 5-point scales. Each item assessed quality and importance. The questionnaire is validated with Cronbach's alphas of 0.86 and 0.91 for the scales respectively.
From enrollment to the end of treatment at 5 weeks
Satisfaction on simulations
Time Frame: From enrollment to the end of treatment at 5 weeks
After the individual and group debriefings. For this purpose, the High Fidelity Clinical Simulation satisfaction scale in students (ESSAF) will be used. This scale contains 33 statements answered on a 5-point Likert-type scale, with a minimum score of 1 (strongly disagree) to 5 (strongly agree). The 33 items are grouped into 8 factors or dimensions of student perception of the simulation clinic: "Usefulness", "Characteristics of cases and applications", "Communication", "Perceived performance", "Increased self-confidence", "Relationship between theory and practice", "Facilities and equipment" and "Positive aspects". It is validated with a Cronbach's alpha of 0.857.
From enrollment to the end of treatment at 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cadiz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2025

Primary Completion (Actual)

April 30, 2025

Study Completion (Actual)

May 23, 2025

Study Registration Dates

First Submitted

February 22, 2025

First Submitted That Met QC Criteria

February 27, 2025

First Posted (Actual)

March 4, 2025

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

June 30, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 087_2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data related to the research, including those related to the participants (preserving anonymity), will be registered in a public data repository (institutional or international).

IPD Sharing Time Frame

  • Study Protocol: February 2025 - March 2025.
  • SAP: March 2025 - December 2025.
  • ICF: March 2025 - December 2025.
  • Analytic Code: March 2025 - December 2025.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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