Wellbeing and Stress Among Mobile Phone Dispatched Lay Responders

Wellbeing and Stress Among Lay Responders Dispatched to Suspected Out-of-hospital Cardiac Arrests

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.

Study Overview

• Status: Terminated
• Conditions: Stress, Psychological; Post-traumatic Stress
• Intervention / Treatment: Other: Exposure: First on scene

Detailed Description

Please see the attacehd study protocol for details

• Study Type: Observational
• Enrollment (Actual): 460

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Västra Götaland
  • Stockholm, Sweden
    • Stockholm, Sweden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; To be first on scene for resuscitation at the suspected out-of hospital cardiac arrest, before EMS and first responders (fire and police services)
Non-dispatched lay responders; Nearby mobile phone located lay responders who have neither actively, nor technically responded due to either human or technical factors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of post traumatic stress symptoms	PCL checklist, short form with 6 items each ranging from 1 to 5. Max is 30 points and a positive screen is a score of ≥ 14 points.	At 90 minutes and 4 at weeks
Level of wellbeing	WHO index, 5 questions each ranging from 5-1 with a maximum of 100 points were higher values indicate good wellbeing. A score below 14 indicates poor wellbeing.	At 4 weeks

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Uppsala University; Vastra Gotaland Region; Stockholm Region; ESCAPE-NET investigators
• Investigators: Principal Investigator: Mattias Ringh, MD PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 9, 2019
• Primary Completion (ACTUAL): May 7, 2020
• Study Completion (ACTUAL): May 7, 2020

Study Registration Dates

• First Submitted: November 11, 2019
• First Submitted That Met QC Criteria: November 15, 2019
• First Posted (ACTUAL): November 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 13, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: Karolinskal007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No