NCT07042061

Brief Summary

The goal of this clinical trial is to learn the feasibility of equipping the volunteer community responders (VCR) with the mobile external automated defibrillators (mAEDs) for the management of adults experiencing out-of-hospital cardiac arrest (OHCA) patients. It will also provide early signals if this enhanced system can help increase the frequency of defibrillation and doing it earlier. The main questions it aims to answer are:

  • Can equipped VCRs apply mAEDs more frequently and earlier to potentially get more patients successfully resuscitated?
  • Is this system enhancement is feasible in the long run. Participants, the VCRs, will:
  • Carry a 450 gm mAED with them all the time for up to an year and use it on an OHCA patient if and when alerted to help.
  • They will hand over this single-use battery-operated device to the EMS crew for data retrieval and potential replacement
  • They will be interviewed for their experience of being equipped and use of the mAED.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started May 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
May 2026Jan 2027

First Submitted

Initial submission to the registry

June 4, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 27, 2025

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

April 27, 2026

Status Verified

June 1, 2025

Enrollment Period

8 months

First QC Date

June 4, 2025

Last Update Submit

April 23, 2026

Conditions

Keywords

Out-of-hospitalCardiac arrestAutomated external defibrillatorAEDCommunity volunteers

Outcome Measures

Primary Outcomes (1)

  • Feasibility of a full scale trial

    A validated AIM/FIM tool will be used to collect perceptions of the users and managers using a likert scale measurement reporting on feasibility and acceptability of the intervention

    Through study completion, an average of 1 year

Secondary Outcomes (3)

  • Qualitative experiences of CFR elicited through semi-structured interviews

    1 year

  • Qualitative experiences of CFR elicited through semi-structured interviews

    1 year

  • Qualitative experiences of CFR elicited through semi-structured interviews

    1 year

Other Outcomes (3)

  • Exploratory outcome mesaures

    1 year

  • Exploratory outcome mesaures

    1 year

  • Exploratory outcome mesaures

    1 year

Study Arms (1)

AED arm

EXPERIMENTAL
Device: Mobile external automated defibrillator

Interventions

A single-use, hand-held, chocolate bar sized portable AED

AED arm

Eligibility Criteria

Age21 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be proficient in English. Able to read and understand English fluently.
  • Be aged 21-74 years of age at point of recruitment.
  • Willing and able to move rapidly to a scene that can be 400 meters away from their location.
  • Be a registered CFR with SCDF.
  • Must be active myResponder® mobile phone app user so they can receive alerts about nearby OHCA cases.

You may not qualify if:

  • Not proficient in English. Cannot read and understand English.
  • Aged less than 21 and over 74 years of age.
  • Not willing to be a myResponder app user.
  • Not able to move rapidly to a scene that can be 400 meters away from their location.
  • Given the short duration of the trial, those who are pregnant will be ineligible.
  • Those experiencing any serious physical injury or handicap and those with obvious mental handicap.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

    PMID: 28851459BACKGROUND

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestHeart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Garion Senior Executive

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2025

First Posted

June 27, 2025

Study Start

May 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 31, 2027

Last Updated

April 27, 2026

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

The trial include government owned information and hence cannot be released.