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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
University of Nevada, Reno
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cardiac Arrest, Out-Of-Hospital focused on measuring Cardiopulmonary Resuscitation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
January 13, 2023
Last Updated
June 9, 2023
Sponsor
University of Nevada, Reno
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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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