Stress, PsychologicalNCT04165668
Wellbeing and Stress Among Mobile Phone Dispatched Lay Responders
An observational study of Stress, Psychological and Post-traumatic Stress, run by Karolinska Institutet at 2 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Post-traumatic Stress
- What is being tested?
- Exposure: First on scene
- How many people
- 460 participants
- Where
- 2 sitesSweden
- Study dates
- 9 Jan 2019to 7 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Lay responders participating as volunteers in the Heartrunner system in regions of Stockholm and Västra Götaland.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
Read the detailed description
Please see the attacehd study protocol for details
- Conditions
- Stress, Psychological, Post-traumatic Stress
- Being tested
- Exposure: First on scene
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure: First on sceneOther
To be first on scene for resuscitation at the suspected out-of hospital cardiac arrest, before EMS and first responders (fire and police services)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 90 minutes and 4 at weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: At 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start9 Jan 2019
- Primary completion7 May 2020
- Study completion7 May 2020
Why it stopped: Due to the COVID-19 Pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, Vastra Gotaland Region, Uppsala University, ESCAPE-NET investigators
- Responsible party
- Principal investigator, Mattias Ringh, Karolinska Institutet
- Investigators
- Mattias Ringh, MD PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165668
- Sponsor's protocol ID
- Karolinskal007
- Status last verified
- Oct 2020
- First submitted
- 11 Nov 2019
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wellbeing and Stress Among Lay Responders Dispatched to Suspected Out-of-hospital Cardiac Arrests
- ClinicalTrials.gov ID
- NCT04165668
- Acronym / sponsor ID
- Karolinskal007
- Conditions
- Stress, Psychological, Post-traumatic Stress
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to the COVID-19 Pandemic.
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm, Vastra Gotaland Region, Uppsala University, ESCAPE-NET investigators
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 7 May 2020 (actual)
- Study completion
- 7 May 2020 (actual)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dispatched lay responders | – | Other: Exposure: First on sceneNearby mobile phone located and dispatched lay responders who reached the place of the suspected OHCA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Lay responders participating as volunteers in the Heartrunner system in regions of Stockholm and Västra Götaland.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure: First on sceneTo be first on scene for resuscitation at the suspected out-of hospital cardiac arrest, before EMS and first responders (fire and police services) | Other | Dispatched lay responders |
Primary outcome
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.
2 secondary outcomes
Level of post traumatic stress symptoms
Time frame: At 90 minutes and 4 at weeks
Level of wellbeing
Time frame: At 4 weeks
Results and safety
The study was stopped early (reason given: Due to the COVID-19 Pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mattias Ringh, MD PhD principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress, Psychological and Post-traumatic Stress, run by Karolinska Institutet at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to the COVID-19 Pandemic.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Level of stress at 4 weeks (time frame: At 90 minutes and 4 at weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.