Overcoming Barriers to Performing CPR Using a Novel, Interactive CPR Game System
Primary Purpose
Cardiac Arrest, Out-Of-Hospital
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CPR Training
Sponsored by
About this trial
This is an interventional other trial for Cardiac Arrest, Out-Of-Hospital focused on measuring Cardiopulmonary Resuscitation
Eligibility Criteria
Inclusion Criteria: All 8th and 9th grade students at participating schools enrolled in Health Class. Exclusion Criteria: Previous CPR training (will be included in the CPR training but excluded from analysis) Physical injury which prevents performing CPR Student or parent opt-out
Sites / Locations
- University of Nevada RenoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Standard CPR Training
CPR Game
Arm Description
Standard CPR training via American Heart Association or American Red Cross provided for 30 minutes during a high school class
Novel CPR game experience CPR training is provided for 30 minutes during a high school class.
Outcomes
Primary Outcome Measures
CPR Skill Retention
High-quality CPR as measured by compression rate (per minute) and depth (inches). High-quality CPR is defined as correct rate (100-120/min) AND >70% of compressions at appropriate depth (2-2.4inches).
Secondary Outcome Measures
CPR Attitudes
A novel questionnaire developed for the study asks Likert-scale questions (scale of 1 to 5, with 5 being VERY LIKELY and 1 being VERY UNLIKELY) regarding attitudes towards performing CPR and overcoming barriers to performing CPR.
Full Information
NCT ID
NCT05908500
First Posted
January 13, 2023
Last Updated
June 9, 2023
Sponsor
University of Nevada, Reno
1. Study Identification
Unique Protocol Identification Number
NCT05908500
Brief Title
Overcoming Barriers to Performing CPR Using a Novel, Interactive CPR Game System
Official Title
Overcoming Barriers to Performing CPR Using a Novel, Interactive CPR Game System
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
January 1, 2027 (Anticipated)
Study Completion Date
January 2, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nevada, Reno
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The goal of this prospective trial is to compare CPR skill and attitudes in adolescent students. The main question[s] it aims to answer are:
Does a gamified CPR experience improve CPR skill retention compared to standard classroom CPR training?
Does a gamified CPR experience improve attitudes/knowledge relating to barriers for women and minorities receiving CPR?
Participants will
Answer pre-training questionnaires
Participate in CPR training
Participate in CPR skills testing on the day of training, and at 4-6 months
Answer post-training questionnaires
Researchers will compare standard CPR classroom training to the novel gamified CPR training experience, which includes an interactive film, a CPR Trainer spring, and a mobile device app.
Detailed Description
We will investigate the effectiveness of the gamified CPR experience (Trainer + app + film + software). The study will be a prospective, cluster-randomized controlled trial with 2 arms: control (standard instructor-led CPR training), and gamified experience. The intervention and cluster randomization will occur at the classroom level and outcomes reported at the individual level. We assume negligible intra-class correlation because classes will be randomized in an alternating fashion to eliminate time-of-day differences. For example, 1st period is randomized to control, 2nd period to game.
CPR training (control or game method) will occur at the beginning of each semester in 8th or 9th grade Health class. Immediately after training, students will perform 2-min of CC, while the app silently measures CC rate and depth. Pre- and post-training questionnaires assessing knowledge and response to female-specific and ethnic CPR barriers will be administered via paper-pencil. At the end of the semester (4 months), students will again perform 2-min of CC and answer questionnaires. All data will be collected on-site in paper-pencil format, and entered into Excel by research coordinator off-site. All data will be de-identified and reported in aggregate form
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Out-Of-Hospital
Keywords
Cardiopulmonary Resuscitation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will be a prospective, cluster-randomized controlled trial with 2 arms: control (standard instructor-led CPR training), and gamified experience. The intervention and cluster randomization will occur at the classroom level and outcomes reported at the individual level. We assume negligible intra-class correlation because classes will be randomized in an alternating fashion to eliminate time-of-day differences. For example, 1st period is randomized to control, 2nd period to game.
Masking
Outcomes Assessor
Masking Description
The statistical analysis will be masked as to which intervention subjects received, with a simple "A" and "B" designation for the 2 arms.
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard CPR Training
Arm Type
Other
Arm Description
Standard CPR training via American Heart Association or American Red Cross provided for 30 minutes during a high school class
Arm Title
CPR Game
Arm Type
Active Comparator
Arm Description
Novel CPR game experience CPR training is provided for 30 minutes during a high school class.
Intervention Type
Other
Intervention Name(s)
CPR Training
Intervention Description
Various methods of CPR training are implemented and compared
Primary Outcome Measure Information:
Title
CPR Skill Retention
Description
High-quality CPR as measured by compression rate (per minute) and depth (inches). High-quality CPR is defined as correct rate (100-120/min) AND >70% of compressions at appropriate depth (2-2.4inches).
Time Frame
4-6 months
Secondary Outcome Measure Information:
Title
CPR Attitudes
Description
A novel questionnaire developed for the study asks Likert-scale questions (scale of 1 to 5, with 5 being VERY LIKELY and 1 being VERY UNLIKELY) regarding attitudes towards performing CPR and overcoming barriers to performing CPR.
Time Frame
4-6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All 8th and 9th grade students at participating schools enrolled in Health Class.
Exclusion Criteria:
Previous CPR training (will be included in the CPR training but excluded from analysis)
Physical injury which prevents performing CPR
Student or parent opt-out
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lorrel Toft, MD
Phone
4103028456
Email
ltoft@unr.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorrel Toft
Organizational Affiliation
University of Nevada, Reno
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nevada Reno
City
Reno
State/Province
Nevada
ZIP/Postal Code
89557
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorrel Toft
Phone
410-302-8456
Email
ltoft@unr.edu
First Name & Middle Initial & Last Name & Degree
Lorrel Toft, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
All data is gathered and reported in de-identified, aggregate form, per IRB and school official direction.
Learn more about this trial
Overcoming Barriers to Performing CPR Using a Novel, Interactive CPR Game System
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