Wellbeing and Stress Among Mobile Phone Dispatched Lay Responders

NCT04165668 | Terminated

• 1 other identifier: Karolinskal007
• Study Type: observational
• Target: 460
• Locations: 1 country
• Sites: 2

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.

Conditions

Stress, Psychological; Post-traumatic Stress

Outcome Measures

Primary Outcomes (1)

• Change in Level of stress at 4 weeks

  Swedish Core Affect Scale (SCAS);The measure of state of mind will be done on 12 affective scales of adjective pairs that range from 1-9. For example: anxious (1) to calm (9), pessimistic (1) to optimistic (9) etc. High numbers on adjectives indicating activation, as well as measures on "Anxious", "tense" and "nervous" will be regarded as (negative) stress whereas "Interested" "engaged" and "optimistic" will be regarded as (positive) stress.

  At 90 minutes and 4 at weeks

Secondary Outcomes (2)

• Level of post traumatic stress symptoms

  At 90 minutes and 4 at weeks

• Level of wellbeing

  At 4 weeks

Study Arms (2)

Dispatched lay responders

Nearby mobile phone located and dispatched lay responders who reached the place of the suspected OHCA before EMS and first responders (fire and police services).

Other: Exposure: First on scene

Non-dispatched lay responders

Nearby mobile phone located lay responders who have neither actively, nor technically responded due to either human or technical factors.

Interventions

Exposure: First on scene OTHER

To be first on scene for resuscitation at the suspected out-of hospital cardiac arrest, before EMS and first responders (fire and police services)

Dispatched lay responders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Lay responders participating as volunteers in the Heartrunner system in regions of Stockholm and Västra Götaland.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator
• Vastra Gotaland Region: collaborator
• Uppsala University: collaborator
• ESCAPE-NET investigators: collaborator

Study Sites (2)

Västra Götaland

Gothenburg, Sweden

Location

Stockholm, Sweden

Stockholm, Sweden

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Mattias Ringh, MD PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 18, 2019
• Study Start: January 9, 2019
• Primary Completion: May 7, 2020
• Study Completion: May 7, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

SE (2)