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Wellbeing and Stress Among Mobile Phone Dispatched Lay Responders

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ClinicalTrials.gov Identifier: NCT04165668
Recruitment Status : Terminated (Due to the COVID-19 Pandemic.)
First Posted : November 18, 2019
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
Stockholm Region
Vastra Gotaland Region
Uppsala University
ESCAPE-NET investigators
Information provided by (Responsible Party):
Mattias Ringh, Karolinska Institutet

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.


Condition or disease Intervention/treatment
Stress, Psychological Post-traumatic Stress Other: Exposure: First on scene

Detailed Description:
Please see the attacehd study protocol for details

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Study Type : Observational
Actual Enrollment : 460 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Wellbeing and Stress Among Lay Responders Dispatched to Suspected Out-of-hospital Cardiac Arrests
Actual Study Start Date : January 9, 2019
Actual Primary Completion Date : May 7, 2020
Actual Study Completion Date : May 7, 2020

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.



Primary Outcome Measures :
  1. Change in Level of stress at 4 weeks [ Time Frame: At 90 minutes and 4 at 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.


Secondary Outcome Measures :
  1. Level of post traumatic stress symptoms [ Time Frame: At 90 minutes and 4 at weeks ]
    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.

  2. Level of wellbeing [ Time Frame: At 4 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Lay responders participating as volunteers in the Heartrunner system in regions of Stockholm and Västra Götaland.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04165668


Locations
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Sweden
Västra Götaland
Gothenburg, Sweden
Stockholm, Sweden
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet
Stockholm Region
Vastra Gotaland Region
Uppsala University
ESCAPE-NET investigators
Investigators
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Principal Investigator: Mattias Ringh, MD PhD Karolinska Institutet
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Responsible Party: Mattias Ringh, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04165668    
Other Study ID Numbers: Karolinskal007
First Posted: November 18, 2019    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms