Clinical trial NCT04165668: Wellbeing and Stress Among Mobile Phone Dispatched Lay Responders
Official title: Wellbeing and Stress Among Lay Responders Dispatched to Suspected Out-of-hospital Cardiac Arrests
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Stress, Psychological
Post-traumatic Stress
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
name: Vastra Gotaland Region
name: Uppsala University
name: ESCAPE-NET investigators
First posted: 2019-11-18
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Lay responders participating as volunteers in the Heartrunner system in regions of Stockholm and Västra Götaland.

Brief summary: The aim of this study is to provide detailed information on state of mind, psychological wellbeing and stress for lay responders dispatched to suspected OHCA via a mobile phone application.

The Heartunner system is a mobile phone positioning system for dispatch of CPR-trained lay volunteers to nearby suspected out-of-hospital cardiac arrests (OHCAs). After downloading of a mobile phone application (The Heartrunner application), and given consent of participation, the lay responders are dispatched to nearby suspected OHCA. The lay responders are either dispatched directly to the scene of the suspected OHCA to perform CPR, or to fetch the nearest AED. The location of the OHCA and available AEDs are displayed on a map, facilitated by the Heartrunner application. The Heartrunner system is studied through "The SAMBA-trial" on clinical outcomes for OHCA patients (ClinicalTrials.gov Identifier: NCT02992873).

The psychological effects among the lay responders will be evaluated with an online survey adjacent to dispatch and after 4-6 weeks. The results of the survey will be compared both intra-individual, and to a control group of not dispatched lay responders within the Heartrunner system. Descriptive statistics regarding interventions, age, gender and former experience will also be presented.

Detailed description: Please see the attacehd study protocol for details

Eligibility criteria: Inclusion Criteria:

* Mobile phone dispatched lay responders who reached the scene a suspected cardiac arrest.
* Located lay responders who was not dispatched due to technical or human reasons (no feedback from app to system).

Exclusion Criteria:

* Mobile Phone Lay responders who declined the mission for dispatch to a suspected cardiac arrest.
* Mobile Phone Lay responders that already answered the survey.
* Mobile phone dispatched lay responders who accepted the mission but was aborted due to distance or did not reach the scene.

Primary outcomes:
measure: Change in Level of stress at 4 weeks
timeFrame: At 90 minutes and 4 at weeks
Secondary outcomes:
measure: Level of post traumatic stress symptoms
timeFrame: At 90 minutes and 4 at weeks
measure: Level of wellbeing
timeFrame: At 4 weeks
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Västra Götaland
city: Stockholm
country: Sweden
facility: Stockholm, Sweden
Study officials:
affiliation: Karolinska Institutet
name: Mattias Ringh, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: