- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07615114
The Effect of ECG Rhythm Virtual Interventions to ECG Interpretation and Competence
The Effect of ECG Rhythm Virtual Interventions to ECG Interpretation and Competence in Finnish University Hospitals
The aim of this study is to develop, implement, and evaluate the effects of a virtual ECG rhythm intervention on the interpretation and competence of cardiology nurses in Finnish university hospitals. The virtual ECG rhythm intervention consists of a virtual animation component and a virtual simulation component, both incorporating cardiological patient cases with corresponding ECG rhythms. The virtual animation includes educational content on a total of 31 different ECG rhythms, as well as a virtual simulation containing 6-8 different cardiological patient cases with ECG rhythms (covering 11 distinct rhythms).
The study employs a quasi-experimental design. Cardiology nurses are divided into two groups based on hospital: an intervention group and a control group.
In this study, data will first be collected for the virtual animation component during 2026-2027, followed by data collection for the virtual simulation component during 2027-2028. A baseline measurement of ECG interpretation and competence will be conducted for both groups (n = 508) using an online survey (LimeSurvey) prior to the intervention.
The same measurement schedule will be applied to the virtual simulation component during the 2027-2028 data collection period.
In this study, three (3) reminder letters will be sent at weekly intervals to encourage participation in the study, its surveys, and the virtual interventions. These reminder messages will be distributed via email by unit managers or equivalent personnel in each hospital to the participants.
The virtual intervention will be delivered online via a web service (GitHub) link. Research data on ECG interpretation and competence will be collected using an ECG interpretation measurement instrument administered through an electronic survey (LimeSurvey).
The ECG interpretation instrument was previously developed by the researcher and includes ECG recordings from real patient cases, for which prior permission has been obtained in accordance with the practices of a cardiac care unit in a central hospital. The instrument has been partially updated in terms of ECG rhythms, with additional new ECG recordings included. Permission for the new ECG recordings was obtained in April 2023 from a Finnish wellbeing services county. The instrument also includes ECG recordings from a simulation monitor display.
The ECG interpretation instrument begins with 14 background questions. It includes five questions assessing ECG competence and currently contains 31 ECG interpretation questions, compared to the previous 21 items. Additionally, the end of the instrument includes seven questions assessing the experiences of participants in the intervention group regarding the virtual intervention.
These implementation methods aim to control for the potential influence of external variables, as the intervention and survey are identical for all participants. This consistency could not be guaranteed if the virtual ECG interpretation intervention were delivered, for example, as a traditional theory-based lecture.
The results of the study will be analyzed using statistical methods. The findings can be utilized, for example, in the development of ECG rhythm interpretation and competence training programs for cardiology nurses.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
During the 2026-2027 data collection phase, participants in the intervention group (n = 254) will use the virtual ECG rhythm animation intervention for one month. The experiences of cardiology nurses regarding the virtual ECG rhythm intervention will be collected during the intervention through open-ended questions.
A second measurement of ECG interpretation and competence will be conducted immediately after the intervention (one month after the baseline) for both groups: the intervention group (n = 254) and the control group (n = 254). A third measurement will be conducted three months after the intervention, again for both groups.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- cardiology nurses
Exclusion Criteria:
- doctors
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Intervention group
Data will first be collected for the virtual animation component during 2026-2027, followed by data collection for the virtual simulation component during 2027-2028.
A baseline measurement of ECG interpretation and competence will be conducted for both groups (n = 508) using an online survey (LimeSurvey) prior to the intervention.
During the 2026-2027 data collection phase, participants in the intervention group (n = 254) will use the virtual ECG rhythm animation intervention for one month.
The experiences of cardiology nurses regarding the virtual ECG rhythm intervention will be collected during the intervention through open-ended questions.
A second measurement of ECG interpretation and competence will be conducted immediately after the intervention (one month after the baseline) for both groups.
A third measurement will be conducted three months after the intervention, again for both groups.
The same measurement schedule will be applied to the virtual simulation component.
|
In this study, data will first be collected for the virtual animation component during 2026-2027, followed by data collection for the virtual simulation component during 2027-2028. A baseline measurement of ECG interpretation and competence will be conducted for both groups (n = 508) using an online survey (LimeSurvey) prior to the intervention. During the 2026-2027 data collection phase, participants in the intervention group (n = 254) will use the virtual ECG rhythm animation intervention for one month. The experiences of cardiology nurses regarding the virtual ECG rhythm intervention will be collected during the intervention through open-ended questions. A second measurement of ECG interpretation and competence will be conducted immediately after the intervention (one month after the baseline) for both groups: the intervention group (n = 254) and the control group (n = 254). A third measurement will be conducted three months after the intervention, again for both groups. |
|
Nessun intervento: Control group
A baseline measurement of ECG interpretation and competence will be conducted for both groups (n = 508) using an online survey (LimeSurvey).
A second measurement of ECG interpretation and competence will be conducted immediately after the intervention (one month after the baseline) for both groups.
And final, third measurement will be conducted three months after the intervention, again for both groups.
The respondents in the control group will continue with standard practice while intervention, meaning that they will not receive any educational material related to ECG interpretation and competence.
Instead, learning ECG rhythms will rely on their usual learning processes, such as workplace-based learning.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
ECG Interpretation skills
Lasso di tempo: from the start of the intervention until its completion, for a period of three months
|
Questionnaire (ECG interpretation Scale) is used to assess ECG interpretation skills and expertise
|
from the start of the intervention until its completion, for a period of three months
|
|
ECG Interpretation Scale
Lasso di tempo: From participation to the end of the intervention (3 months)
|
The ECG interpretation instrument begins with 14 background questions. It includes five questions assessing ECG competence and currently contains 31 ECG interpretation questions. Answers on the ECG interpretation section are scored such that a correct answer earns one point and an incorrect answer earns zero points. The maximum score on the questionnaire is 31, indicating a very high level of proficiency in ECG interpretation. |
From participation to the end of the intervention (3 months)
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 38/2026
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Elettrocardiogramma
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Centre Hospitalier Universitaire de Saint EtienneAssociation CNGE IRMGTerminatoIndicazione per ElectroCardioGramFrancia
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