CPR Education Via a Mobile Application Compared to VSI Kit

January 15, 2019 updated by: University of Pennsylvania

CPR Education for Families of Cardiac Patients Before Hospital Discharge

Prompt delivery of cardiopulmonary resuscitation (CPR) is a crucial determinant of survival for many victims of sudden cardiac arrest (SCA), yet bystander CPR is provided in less than one third of witnessed SCA events. A number of barriers to bystander CPR training have been identified including time and cost of the training course. Since the large majority of arrest events occur in the home environment, studies have suggested that providing CPR training to family members of hospitalized cardiac patients may serve as a useful approach to address an environment in which bystander CPR is frequently not provided. Utilizing an existing in-hospital program to train adult family members, the investigators will assess the skills of those who learn CPR through two different educational methods: a mobile app and video self-instruction (VSI).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The long term goal of the investigators work is to implement real world CPR training strategies that match training locales with at-risk populations, maximize resuscitation skill retention, and promote willingness to act. To accomplish this, the investigators will empower stakeholders at the University of Pennsylvania Health System (UPHS) and local area hospitals to develop local implementation approaches, using either volunteer hospital personnel or paid research assistants as training proctors. These stakeholders will be studied as a research subset. The training proctors will educate family members or friends of patients at risk for cardiac arrest using a mobile application "app" or VSI kit (RCT), and empower them with the lifesaving skill of CPR. The investigators will follow up with the study subjects and conduct CPR skills tests 6 to 12 months from the time of training to assess whether the subjects retained their skills or if they had an opportunity to use the skills that they learned. The investigators will also gather information on how the subjects would like to be encouraged to practice their skills. The investigators will send a reminder notification every two months following training, to encourage subjects to refresh their training skills. At the follow-up skills test at 6 to 12 months, the investigators will administer a survey to assess whether the prompting encouraged the subjects to practice their skills. Additionally the investigators will encourage the individuals trained in-hospital to share the kit or mobile app with others. The investigators will follow-up with those who are identified as secondary trainees to assess the environment in which secondary training took place.

Study Type

Interventional

Enrollment (Actual)

1679

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Presbyterian Medical Center
      • Philadelphia, Pennsylvania, United States, 19106
        • Pennsylvania Hospital
      • Upland, Pennsylvania, United States, 19013
        • Crozer-Keystone Health System
      • West Chester, Pennsylvania, United States, 19380
        • The Chester County Hospital and Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must be present with their family member at the hospital
  • The family member must be at high risk for cardiac arrest (CA), including:
  • previous myocardial infarction (MI)
  • previous CA
  • history of diabetes
  • history of high cholesterol
  • history of high blood pressure
  • This includes subjects with family members being discharged from the Cardiac Intermediate Care Unit (CICU), Telemetry units, ICU, Cardiac Care Unit (CCU), cardiology clinics, or physicians office within the participating hospitals/health systems

Exclusion Criteria:

  • Volunteers and subjects must be 18 years of age or older
  • Individual must be fit and able to perform moderate physical activity
  • Volunteers must be English speaking and/or Spanish speaking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: VSI Kit
Education: CPR Training using the CPR Anytime VSI Kit Individuals will learn chest-compression only CPR (no rescue breaths) using the American Heart Association's Family and Friends CPR Anytime Kit. Subjects will undergo training in-hospital and will be encouraged to take the kit home to share with their family members and friends.
Other: Education: CPR Training using the CPR Anytime VSI Kit
Subjects will be trained using the American Heart Association's Family and Friends CPR Anytime Kit. Subjects will undergo training in-hospital and will be encouraged to take the kit home to share with their family members and friends.
Other Names:
  • Family and Friends CPR Anytime
  • American Heart Association Family and Friends CPR Anytime
  • CPR Anytime Video Self Instruction (VSI)
Experimental: Mobile Application
Education: CPR Training via Mobile App Individuals will learn chest-compression only CPR (no rescue breaths) using a newly developed mobile training application.
Other: Education: CPR Training via Mobile App
Using a mobile app to train users on chest-compression only CPR. Subjects will be encouraged to share the app with family and friends.
Other Names:
  • CPR Training Cellphone App

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chest compression depth
Time Frame: 6 months
Depth of chest compression performed by the subject, recorded using the Laerdal SimPad®. This metric will be measured in millimeters (mm). This outcome measure will be collected by research coordinators during 6-month in-home follow-up visits.
6 months
Chest compression rate
Time Frame: 6 months
Rate of chest compressions performed by the subject, recorded using the Laerdal SimPad®. This metric will be measured as the number of compressions performed in a 2 minute window. This outcome measure will be collected by research coordinators during 6-month in-home follow-up visits.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary CPR training rates
Time Frame: 6 months
Calculate the number of secondary trainees based on study participant self-reporting (via survey) collected during the 6-month follow-up.
6 months
Incidence of bystander CPR provided by subjects
Time Frame: 6-12 months
Using 6 month and 12 month follow-up surveys, subjects will be asked if they had an opportunity to use their CPR skills in a real-life situation and whether or not they performed CPR in the aforementioned situation.
6-12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative analysis of patient's perspective of the family member's receiving hands-only CPR training using semi-structured
Time Frame: 6-12 months
Using semi-structured interviews, we will evaluate the impact that CPR training of the patient's family may have on the patient's sense of independence and self-care post-discharge. Analysis will be based on the grounded theory. A working set of thematic codes will be identified and applied to all interview transcriptions using NVivo10. Thematic domains from this descriptive aim will help inform future understanding of the cardiac patient's psychological well-being and preparedness around cardiac disease as well as thoughts towards CPR training.
6-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

Patient-Centered Outcomes Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

August 31, 2015

First Submitted That Met QC Criteria

September 11, 2015

First Posted (Estimate)

September 14, 2015

Study Record Updates

Last Update Posted (Actual)

January 17, 2019

Last Update Submitted That Met QC Criteria

January 15, 2019

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 822593

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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