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CPR Education Via a Mobile Application Compared to VSI Kit

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ClinicalTrials.gov Identifier: NCT02548793
Recruitment Status : Completed
First Posted : September 14, 2015
Last Update Posted : January 17, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of Pennsylvania

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).

Condition or disease Intervention/treatment Phase
Cardiovascular Risk Factors Coronary Disease Cardiac Arrest Other: Education: CPR Training via Mobile App Other: Education: CPR Training using the CPR Anytime VSI Kit Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1679 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: CPR Education for Families of Cardiac Patients Before Hospital Discharge
Study Start Date : January 2016
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


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 Name: CPR Training Cellphone App




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02548793


Locations
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United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19106
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Crozer-Keystone Health System
Upland, Pennsylvania, United States, 19013
The Chester County Hospital and Health System
West Chester, Pennsylvania, United States, 19380
Sponsors and Collaborators
University of Pennsylvania
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Benjamin S Abella, MD, MPhil University of Pennsylvania

Additional Information:
Publications:

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02548793     History of Changes
Other Study ID Numbers: 822593
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: October 2018
Keywords provided by University of Pennsylvania:
Cardiac Arrest
CPR
Family-centered Care
Health Literacy
Health Education
Education Dissemination
Additional relevant MeSH terms:
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Heart Arrest
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases