Wellbeing and Stress Among Mobile Phone Dispatched Lay Responders

Stress, Psychological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04165668
• Other study ID #: Karolinskal007
• Status: Terminated
• Start date: January 9, 2019
• Est. completion date: May 7, 2020

Study information

• Verified date: October 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Please see the attacehd study protocol for details

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 460
• Est. completion date: May 7, 2020
• Est. primary completion date: May 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Post-traumatic Stress
• Stress, Psychological

Intervention

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)

Locations

Country	Name	City	State
Sweden	Västra Götaland	Gothenburg
Sweden	Stockholm, Sweden	Stockholm

Sponsors (5)

Lead Sponsor	Collaborator
Karolinska Institutet	ESCAPE-NET investigators, Stockholm Region, UPPSALA UNIVERSITET, Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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