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MultimorbidityNCT06855719

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

A study testing Training in high-fidelity simulation and knowledge of care protocols in patients with multimorbidity and heart failure in people with Multimorbidity and Heart Failure, run by University of Cadiz at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Multimorbidity, Heart Failure
What is being tested?
Training in high-fidelity simulation and knowledge of care protocols in patients with multimorbidity and heart failure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteSpain
Study dates
10 Mar 2025to 23 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Faculty of Nursing

    Algeciras, Cadiz, 11207

Other trials in Spain

About this study

Official title: 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?
Read more

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).
Being tested
Training in high-fidelity simulation and knowledge of care protocols in patients with multimorbidity and heart failure
Keywords
High Fidelity Simulation Training, Patient Simulation, Home Health Nursing, Primary Care Nursing, Family Nursing, Nursing Education Research, Students, Nursing, Education, Nursing
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Training in high-fidelity simulation and knowledge of care protocols in patients with multimorbidity and heart failureOther

    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.

Study groups in NCT06855719
Study groupRoleWhat they receive
Experimental GroupExperimentalStudents 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.
Receives: Other: Training in high-fidelity simulation and knowledge of care protocols in patients with multimorbidity and heart failure
Control GroupNo interventionStudents will receive only theoretical teaching about primary health care in nursing.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment to the end of intervention at 4 weeks.

  2. 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.

    Measured: From enrollment to the end of treatment at 4 weeks.

Secondary outcomes (3)

  1. Self-confidence in learning

    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.

    Measured: From enrollment to the end of treatment at 5 weeks

  2. Quality of simulations

    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.

    Measured: From enrollment to the end of treatment at 5 weeks

  3. Satisfaction on simulations

    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.

    Measured: From enrollment to the end of treatment at 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2025
  2. Study start10 Mar 2025
  3. Primary completion30 Apr 2025
  4. Study completion23 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a parallel group-randomized controlled trial.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06855719
Sponsor's protocol ID
087_2024
Status last verified
Jun 2025
First submitted
22 Feb 2025
Last updated
3 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data related to the research, including those related to the participants (preserving anonymity), will be registered in a public data repository (institutional or international).

Publications

  • Zeidi IM, Morshedi H, Alizadeh Otaghvar H. A theory of planned behavior-enhanced intervention to promote health literacy and self-care behaviors of type 2 diabetic patients. J Prev Med Hyg. 2021 Jan 14;61(4):E601-E613. doi: 10.15167/2421-4248/jpmh2020.61.4.1504. eCollection 2020 Dec.

    PubMed 33628967

  • Turen S, Enc N. A comparison of Gordon's functional health patterns model and standard nursing care in symptomatic heart failure patients: A randomized controlled trial. Appl Nurs Res. 2020 Jun;53:151247. doi: 10.1016/j.apnr.2020.151247. Epub 2020 Mar 5.

    PubMed 32451005

  • Villalba NL, Ballesteros BC, Alvarez LP, Mainar PD, Sanchez AN, Martinez JM, Manuel EC, Bailon MM. [Predictive factors of early readmission and mortality in patients with heart failure hospitalized in the Department of Internal Medicine of the San Carlos University Hospital, Spain]. Pan Afr Med J. 2019 Dec 17;34:202. doi: 10.11604/pamj.2019.34.202.17356. eCollection 2019. French.

    PubMed 32180876

  • Skou ST, Mair FS, Fortin M, Guthrie B, Nunes BP, Miranda JJ, Boyd CM, Pati S, Mtenga S, Smith SM. Multimorbidity. Nat Rev Dis Primers. 2022 Jul 14;8(1):48. doi: 10.1038/s41572-022-00376-4.

    PubMed 35835758

  • Santos GC, Liljeroos M, Dwyer AA, Jaques C, Girard J, Stromberg A, Hullin R, Schafer-Keller P. Symptom perception in heart failure - Interventions and outcomes: A scoping review. Int J Nurs Stud. 2021 Apr;116:103524. doi: 10.1016/j.ijnurstu.2020.103524. Epub 2020 Jan 10.

    PubMed 32063295

  • Jara Jara V, Sambuceti Nunez C. Clinical Simulation in Nursing: A Scale to Evaluate Satisfaction and Self-Confidence in Learning. Stud Health Technol Inform. 2018;250:89-90.

    PubMed 29857393

  • Merrou S, Baslam A, Idrissi Jouicha A, Ouhaz Z, El Adib AR. Blended learning and simulation in nursing education: A quasi-experimental study on a nursing institute. J Educ Health Promot. 2023 Sep 29;12:303. doi: 10.4103/jehp.jehp_72_23. eCollection 2023.

    PubMed 38023106

  • Martinez-Arce A, Rodriguez-Almagro J, Velez-Velez E, Rodriguez-Gomez P, Tovar-Reinoso A, Hernandez-Martinez A. Validation of a short version of the high-fidelity simulation satisfaction scale in nursing students. BMC Nurs. 2023 Sep 28;22(1):344. doi: 10.1186/s12912-023-01515-2.

    PubMed 37770843

  • Fernandez-Gutierrez M, Bas-Sarmiento P, Del Pino-Chinchilla H, Poza-Mendez M, Marin-Paz AJ. Effectiveness of a multimodal intervention and the simulation flow to improve empathy and attitudes towards older adults in nursing students: A crossover randomised controlled trial. Nurse Educ Pract. 2022 Oct;64:103430. doi: 10.1016/j.nepr.2022.103430. Epub 2022 Aug 22.

    PubMed 36122493

  • Fegran L, Ten Ham-Baloyi W, Fossum M, Hovland OJ, Naidoo JR, van Rooyen DRM, Sejersted E, Robstad N. Simulation debriefing as part of simulation for clinical teaching and learning in nursing education: A scoping review. Nurs Open. 2023 Mar;10(3):1217-1233. doi: 10.1002/nop2.1426. Epub 2022 Nov 9.

    PubMed 36352489

  • Driscoll A, Gao L, Watts JJ. Clinical effectiveness and cost-effectiveness of ambulatory heart failure nurse-led services: an integrated review. BMC Cardiovasc Disord. 2022 Feb 22;22(1):64. doi: 10.1186/s12872-022-02509-9.

    PubMed 35193503

  • De Maria M, Ausili D, Lorini S, Vellone E, Riegel B, Matarese M. Patient Self-Care and Caregiver Contribution to Patient Self-Care of Chronic Conditions: What Is Dyadic and What It Is Not. Value Health. 2022 Jul;25(7):1165-1173. doi: 10.1016/j.jval.2022.01.007. Epub 2022 Mar 23.

    PubMed 35337754

  • Chen J, Aronowitz P. Congestive Heart Failure. Med Clin North Am. 2022 May;106(3):447-458. doi: 10.1016/j.mcna.2021.12.002. Epub 2022 Apr 4.

    PubMed 35491065

  • Bas-Sarmiento P, Fernandez-Gutierrez M, Poza-Mendez M, Marin-Paz AJ, Paloma-Castro O, Romero-Sanchez JM; ASyAG_PPIC Team. Development and Effectiveness of a Mobile Health Intervention in Improving Health Literacy and Self-management of Patients With Multimorbidity and Heart Failure: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Apr 29;11(4):e35945. doi: 10.2196/35945.

    PubMed 35486437

  • Bas-Sarmiento P, Fernandez-Gutierrez M, Poza-Mendez M, Carrasco-Bernal MA, Cuenca-Garcia M, Diaz-Rodriguez M, Gomez-Jimenez MP, Paloma-Castro O, Torres-Castano A, Marin-Paz AJ. Needs of patients with multi-morbidity and heart failure for the development of a mHealth to improve their self-management: A qualitative analysis. Digit Health. 2023 Jun 8;9:20552076231180466. doi: 10.1177/20552076231180466. eCollection 2023 Jan-Dec.

    PubMed 37325072

Questions about this trial

What is this clinical trial studying?

A study testing Training in high-fidelity simulation and knowledge of care protocols in patients with multimorbidity and heart failure in people with Multimorbidity and Heart Failure, run by University of Cadiz at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Learning (time frame: From enrollment to the end of intervention at 4 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06855719, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.

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