- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07607808
Psychological Stress and Support Needs of Volunteer First Responders After Smartphone-based Cardiac Arrest Alerts (BRAVE)
Burden and Resilience After Volunteer Engagement in Out-of-Hospital Cardiac Arrest
Out-of-hospital cardiac arrest is a serious emergency. In many areas, trained volunteers are alerted by a smartphone app to help before emergency services arrive. While this can save lives, these situations can also be emotionally stressful for the volunteers. This study looks at how these experiences affect volunteer first responders and how they cope with them. It also examines whether a structured follow-up conversation after an event can help reduce stress.
People who respond to a cardiac arrest alert can take part in the study. Participants will answer short questionnaires about their well-being about four weeks and ten weeks after the event. Some participants will also be offered a guided conversation to talk about their experience, while others will not.
The researchers will compare both groups to see if the conversation helps reduce stress over time. The study will also explore which factors may increase or reduce emotional burden.
Participants can stop answering the questionnaires at any time. If signs of increased stress are identified, support options are available. With consent, the study team may contact participants to offer further information and help connect them with support services.
The results of this study may help improve support for volunteer first responders in the future.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Out-of-hospital cardiac arrest (OHCA) remains a major cause of mortality worldwide. Early initiation of cardiopulmonary resuscitation by bystanders is a key determinant of survival. To improve response times, many regions have implemented smartphone-based alerting systems that notify nearby volunteer first responders of suspected cardiac arrest events.
While these systems have demonstrated clinical benefits, the psychological impact on volunteer responders is not yet fully understood. Responding to OHCA incidents may involve exposure to emotionally challenging situations, including unsuccessful resuscitation attempts or distressing scene conditions. At the same time, engagement in such life-saving efforts may also be associated with positive psychological effects, such as a sense of meaning or competence. A better understanding of both burden and resilience factors is needed to optimize support strategies for this population.
The BRAVE study (Burden and Resilience After Volunteer Engagement) is designed to investigate the psychological impact of smartphone-based OHCA alerts on volunteer first responders and to evaluate whether a structured post-event debriefing intervention can improve psychological outcomes.
Participants are recruited via the Corhelper smartphone application, which is routinely used to alert volunteer responders. After completing a routine post-event questionnaire, responders may indicate their interest in being contacted about study participation. Only individuals who provide explicit consent will be contacted by the study team and receive detailed study information.
The study follows a randomized controlled design. Participants are prospectively assigned to either an intervention group receiving a structured debriefing conversation or a control group without this intervention. The allocation ratio is approximately 1:2 due to resource constraints related to the delivery of the intervention.
The structured debriefing consists of a guided conversation conducted by a physician member of the study team, with the option to involve trained personnel from the psychosocial support (PSU) team. The conversation focuses on the reconstruction of the event, clarification of medical and situational aspects, and the individual processing of the experience. The intervention aims to support participants in understanding and coping with the event.
Psychological outcomes are assessed using standardized questionnaires at approximately four weeks (T1) and ten weeks (T2) after the event. Symptoms of post-traumatic stress are measured using the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). Personality traits are additionally assessed using the Big Five Inventory (BFI).
Exploratory analyses will additionally assess potential correlations between post-traumatic stress symptoms and individual or event-related factors. These may include prior medical background, previous resuscitation experience, pre-existing personal stress, personality traits measured by the BFI, time to arrival at the scene, resuscitation outcome, and the number of first responders present.
To ensure participant safety, a structured support pathway is implemented. Signs of increased psychological distress are identified based on questionnaire results and/or clinical impression during personal interactions. If indicated, participants may receive additional support, including further conversations with the study team, involvement of the PSU team, or referral to specialized mental health services in cooperation with the Alexianer Center for Mental Health. In the case of questionnaire-based assessments, participants may be contacted proactively by the study team if they have previously consented to such contact.
The study aims to generate evidence on the psychological effects of first responder systems and to evaluate the potential benefit of structured debriefing interventions. The results are expected to inform the development of targeted support strategies for volunteer first responders and contribute to the sustainable implementation of smartphone-based alerting systems.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Mark Pitsch, MD
- Numero di telefono: 0049 241 432 37 6300
- Email: mpitsch@ukaachen.de
Luoghi di studio
-
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North Rhine-Westphalia
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Aachen, North Rhine-Westphalia, Germania, 52068
- Aachen Institute for Rescue Management and Public Safety (ARS), RWTH Aachen University Hospital
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Contatto:
- Mark Pitsch, MD
- Numero di telefono: 0049 241 432 37 6300
- Email: mpitsch@ukaachen.de
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Volunteer first responders alerted through the "Corhelper" smartphone application
- Sufficient German language skills to understand the study information and to participate in the debriefing conversation and questionnaires
- Written informed consent for study participation
- Actual arrival at the scene with direct exposure to the resuscitation situation (e.g., visual contact with the patient or active participation in resuscitation measures)
Exclusion Criteria:
- Age below 18 years
- Anticipated severe post-traumatic stress symptoms during the course of the study, in order to avoid possible retraumatization
- Already enrolled in the study following a different Corhelper alert event
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Nessun intervento: Control (No debriefing)
Participants in this group do not receive the structured debriefing intervention.
They complete the scheduled follow-up questionnaires at predefined time points without additional structured support.
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|
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Sperimentale: Intervention (Structured debriefing)
Participants in this group receive a structured debriefing conversation conducted by a team including physician members of the study team and trained psychosocial support (PSU) personnel.
The conversation focuses on reviewing the event, clarifying medical and situational aspects, and supporting the individual processing of the experience.
|
The intervention consists of a structured debriefing conversation conducted by a team including physician members of the study team and trained psychosocial support (PSU) personnel.
The conversation follows a semi-structured format and includes a guided reconstruction of the event, clarification of medical and situational aspects, and support in the individual processing of the experience.
The aim is to facilitate understanding, reduce uncertainty, and support coping with the event.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Post-traumatic stress symptom severity measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) total score
Lasso di tempo: 4 weeks after the event
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Post-traumatic stress symptoms are assessed using the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5).
Total scores range from 0 to 80, with higher scores indicating greater symptom severity.
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4 weeks after the event
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in post-traumatic stress symptom severity measured by PCL-5 total score
Lasso di tempo: From 4 weeks to 10 weeks after the event
|
Post-traumatic stress symptoms are assessed using the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5).
Total scores range from 0 to 80, with higher scores indicating greater symptom severity.
Change is calculated as the difference between the 10-week and 4-week scores.
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From 4 weeks to 10 weeks after the event
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Difference in post-traumatic stress symptom severity between debriefing and control groups
Lasso di tempo: 4 weeks and 10 weeks after the event
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PCL-5 total scores and changes in PCL-5 total scores are compared between participants assigned to the structured debriefing group and participants assigned to the control group.
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4 weeks and 10 weeks after the event
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Collaboratori e investigatori
Pubblicazioni e link utili
Collegamenti utili
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
Termini MeSH pertinenti aggiuntivi
- Disturbi correlati a traumi e fattori di stress
- Malattia cardiovascolare
- Disordini mentali
- Malattie cardiache
- Sintomi comportamentali
- Disturbi da stress, traumatici
- Comportamento
- Soddisfazione personale
- Arresto cardiaco
- Stress, Psicologico
- Disturbi da stress, post-traumatici
- Arresto cardiaco extraospedaliero
- Benessere psicologico
Altri numeri di identificazione dello studio
- 25-252
- EK 26-029 (Altro identificatore: Ethics Committee of RWTH Aachen University)
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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