The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05983640
Recruitment Status : **RECRUITING NOW**
First Posted : August 9, 2023
Last Update Posted : August 9, 2023
Sponsor:
Brigham and Women’s Hospital
Collaborators:
Massachusetts General Hospital
American Heart Association
Information provided by (Responsible Party):
Eric Goralnick, Brigham and Women’s Hospital
Study Description
Go toÂ
Brief Summary:
The objective is to evaluate the effectiveness of a Just in Time (JiT) video as compared to the AHA Heartsaver® Course and no training (control) in ability to correctly perform CPR. The secondary objective is to assess skill retention 3-9 months after the AHA Heartsaver course with and without JiT Video use. The goal of this work is to study the effectiveness of this new JiT video to improve objective knowledge- and performance-based measures of effective OHCA response, as well as subjective ratings of preparedness and likeliness to respond, compared to the standard AHA Heartsaver® CPR AED Training course.
Condition or disease
Intervention/treatment
Phase
Cardiopulmonary Arrest With Successful Resuscitation Educational Problems
Other: Video Other: AHA course
Not Applicable
Show detailed description
Study Design
Go toÂ
Layout table for study information
Study Type :
Interventional  (Clinical Trial)
Estimated Enrollment :
350 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective, randomized, three arm, parallel, open-label trial
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Just in Time Cardio Pulmonary Resuscitation Trial (JITCPR-T): Comparison of a Brief Video to Traditional CPR Training: a Randomized Controlled Trial
Actual Study Start Date :
March 27, 2023
Estimated Primary Completion Date :
January 1, 2024
Estimated Study Completion Date :
January 1, 2024
Resource links provided by the National Library of Medicine
Arms and Interventions
Go toÂ
Arm
Intervention/treatment
No Intervention: Control
Assessment without training or video prompt
Experimental: Just in time video
Assessment with JiT video available
Other: Video
Just in time training video on hands only CPR
Active Comparator: AHA Course
Assessment after completion of CPR training course
Other: AHA course
AHA Heartsaver CPR course
Outcome Measures
Go toÂ
Primary Outcome Measures :
Performance of correct cardiopulmonary resuscitation (CPR) (Objective Performance) [ Time Frame: Measured within 2 hours of randomization, during the intervention ]
Correct CPR will be measured by successful completion of all five of the following actions:
Calling for 9-1-1 (as measured by verbalizing action to examiner)
Calling for automated external defibrillator (as measured by verbalizing action to examiner)
Placing hand in correct position on manikin chest (as measured by examiner)
Compressing at a rate of 100-120 per minute (as measured by examiner and through CPR manikin equipped with Laerdal QCPR software)
Compressing to a depth of at least 2 inches (as measured by examiner and through CPR manikin equipped with Laerdal QCPR software)
Secondary Outcome Measures :
CPR knowledge (Objective Knowledge) [ Time Frame: Measured immediately after skill evaluation completion ]
Knowledge regarding CPR skills will be measured by an 8-question multiple choice assessment, based on the American Heart Association HeartSaver curriculum. The assessment will test participants’ understanding of when to perform CPR on a victim and how to perform CPR correctly (e.g., hand placement, compression rate, and compression depth). The assessment will be scored as 1 point per correct answer, with a range of 0-8 points (higher score indicates better knowledge).
Change in willingness to respond (Subjective Preparedness) [ Time Frame: Measured within 1 hour before and immediately after skill evaluation completion ]
Participants will complete pre/post 6-question assessments to determine the change in their likelihood and confidence in providing CPR in different situations. Items will be scored on a 5-point Likert-type scale (very unlikely to very likely) for likelihood to perform CPR (for a stranger, close relative for friend, or if requested by a trained professional and confidence in identifying cardiac arrest, performing CPR, and using an AED. Change in willingness to respond will be measured by examining the within-person change from pre and post assessments.
Eligibility Criteria
Go toÂ
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study: Â
18 Years and older  (Adult, Older Adult)
Sexes Eligible for Study: Â
All
Accepts Healthy Volunteers: Â
Yes
Criteria
Inclusion Criteria:
Employee of Gillette Stadium
Exclusion Criteria:
Age less than 18 years
Contacts and Locations
Go toÂ
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): NCT05983640
Contacts
Locations
Layout table for location information
United States, Massachusetts
Gillette Stadium
**RECRUITING NOW**
Foxboro, Massachusetts, United States, 02035
Sponsors and Collaborators
Brigham and Women’s Hospital
Massachusetts General Hospital
American Heart Association
Investigators
Layout table for investigator information
Principal Investigator:
Eric Goralnick, MD, MS
Brigham and Women’s Hospital
More Information
Go toÂ
Layout table for additonal information
Responsible Party:
Eric Goralnick, Associate Professor of Emergency Medicine, Brigham and Women’s Hospital
ClinicalTrials.gov Identifier:
NCT05983640 Â Â
Other Study ID Numbers:
2023P000222
First Posted:
August 9, 2023 Â Â Key Record Dates
Last Update Posted:
August 9, 2023
Last Verified:
August 2023
Layout table for additional information
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eric Goralnick, Brigham and Women’s Hospital:
YoutubeVideo EducationPublic EmpowermentCPRAED
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart ArrestHeart DiseasesCardiovascular Diseases
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
