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CPR Education Via a Mobile Application Compared to VSI Kit

Primary Purpose

Cardiovascular Risk Factors, Coronary Disease, Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education: CPR Training via Mobile App
Education: CPR Training using the CPR Anytime VSI Kit
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Risk Factors focused on measuring Cardiac Arrest, CPR, Family-centered Care, Health Literacy, Health Education, Education Dissemination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cooper University Hospital
  • Hospital of the University of Pennsylvania
  • Penn Presbyterian Medical Center
  • Pennsylvania Hospital
  • Albert Einstein Medical Center
  • Crozer-Keystone Health System
  • The Chester County Hospital and Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

VSI Kit

Mobile Application

Arm Description

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.

Education: CPR Training via Mobile App Individuals will learn chest-compression only CPR (no rescue breaths) using a newly developed mobile training application.

Outcomes

Primary Outcome Measures

Chest compression depth
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.
Chest compression rate
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.

Secondary Outcome Measures

Secondary CPR training rates
Calculate the number of secondary trainees based on study participant self-reporting (via survey) collected during the 6-month follow-up.
Incidence of bystander CPR provided by subjects
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.

Full Information

First Posted
August 31, 2015
Last Updated
January 15, 2019
Sponsor
University of Pennsylvania
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02548793
Brief Title
CPR Education Via a Mobile Application Compared to VSI Kit
Official Title
CPR Education for Families of Cardiac Patients Before Hospital Discharge
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Risk Factors, Coronary Disease, Cardiac Arrest
Keywords
Cardiac Arrest, CPR, Family-centered Care, Health Literacy, Health Education, Education Dissemination

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1679 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VSI Kit
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Mobile Application
Arm Type
Experimental
Arm Description
Education: CPR Training via Mobile App Individuals will learn chest-compression only CPR (no rescue breaths) using a newly developed mobile training application.
Intervention Type
Other
Intervention Name(s)
Education: CPR Training via Mobile App
Other Intervention Name(s)
CPR Training Cellphone App
Intervention Description
Using a mobile app to train users on chest-compression only CPR. Subjects will be encouraged to share the app with family and friends.
Intervention Type
Other
Intervention Name(s)
Education: CPR Training using the CPR Anytime VSI Kit
Other Intervention Name(s)
Family and Friends CPR Anytime, American Heart Association Family and Friends CPR Anytime, CPR Anytime Video Self Instruction (VSI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Chest compression depth
Description
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.
Time Frame
6 months
Title
Chest compression rate
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Secondary CPR training rates
Description
Calculate the number of secondary trainees based on study participant self-reporting (via survey) collected during the 6-month follow-up.
Time Frame
6 months
Title
Incidence of bystander CPR provided by subjects
Description
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.
Time Frame
6-12 months
Other Pre-specified Outcome Measures:
Title
Qualitative analysis of patient's perspective of the family member's receiving hands-only CPR training using semi-structured
Description
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.
Time Frame
6-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin S Abella, MD, MPhil
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Penn Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Crozer-Keystone Health System
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
The Chester County Hospital and Health System
City
West Chester
State/Province
Pennsylvania
ZIP/Postal Code
19380
Country
United States

12. IPD Sharing Statement

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Links:
URL
https://www.med.upenn.edu/resuscitation/
Description
University of Pennsylvania - Center for Resuscitation Science
URL
http://www.heart.org/HEARTORG/
Description
American Heart Association

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CPR Education Via a Mobile Application Compared to VSI Kit

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