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An In-Hospital Family Member Cardiopulmonary Resuscitation (CPR) Education Program

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by University of Pennsylvania.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
American Heart Association
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01260441
First received: November 29, 2010
Last updated: December 13, 2010
Last verified: December 2010
History of Changes
  Purpose

Each year in the United States, 300,000 people suffer from a Cardiac Arrest (CA), and of them, there is a 90% mortality rate. Out-of-Hospital arrests, in particular, have a 1-5% survival to hospital discharge. High quality CPR is crucial to lowering the mortality rate and increasing survival, yet only 15-30% of out-of-hospital CA victims receive bystander CPR. Studies have shown that prompt administration of CPR dramatically improves outcomes. In a recent study from Switzerland, lay bystander CPR doubled the survival rate at one month. Our study will look to train family members of at-risk cardiac patients in the skills of CPR through the American Heart Association's (AHA) CPR Anytime Friends and Family Personal Learning Program (CPR Anytime) to see if these family members are able to learn and perform quality CPR in the event that their family member should suffer a cardiac arrest.


Condition Intervention Phase
Cardiac Arrest
Coronary Disease
Cardiovascular Risk Factors
 Other: CPR Training using the Family and Friends CPR Anytime VSI Kit
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: CPR Education of Patient Family Members Using CPR Anytime Training Program

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Subject Self-Confidence [ Time Frame: within 30 minutes of CPR training ] [ Designated as safety issue: No ]
    We will administer a comprehensive post-training likert scale scoring survey to measure the subject's comfort level using their newly acquired CPR skills.

  • Secondary Training [ Time Frame: 3 month increments over a 12 month period of time ] [ Designated as safety issue: No ]
    In addition, we will administer a telephone survey to measure the subject's secondary training through the CPR Anytime Kit.


Secondary Outcome Measures:
  • Assessing CPR Skills [ Time Frame: 3 to 6 months post-training ] [ Designated as safety issue: No ]
    We will assess the subject's CPR skills by administering a 2-minute simulated CPR skills check recorded on a Laerdal Skillreporter ResusciAnne mannequin and video camera. The skills check will be conducted initially post training and at the 3-, 6-, and 12-month time frame.


Estimated Enrollment: 500
Study Start Date: October 2007
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard CPR
Individuals will learn the Standard form of CPR (30:2, compressions:breathes) Main data points being collected over various increments are: 1) Comfort Level with using CPR 2) Secondary Training "multiplier effect" and 3) CPR Skills
 Other: CPR Training using the Family and Friends 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)
Active Comparator: Chest Compressions Only CPR
Individuals will learn the chest compression only form of CPR (no rescue breathes) Main data points being collected at various increments are: 1) Comfort Level with using CPR 2) Secondary Training "multiplier effect" and 3) CPR Skills
 Other: CPR Training using the Family and Friends 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)

Detailed Description:

Using the AHA's CPR Anytime kit, we will work with family members of patients at high risk for a CA to learn lifesaving CPR skills. We will modify the AHA CPR video using the new AHA recommendations for bystanders which suggests doing chest compression only CPR. Using the original AHA video and our modified chest compression only video, we will randomize family members of patients at high risk for CA to one of these groups. Our research assistants will also be blinded to which video these subjects will be watching. After watching the video, we will have the subjects perform CPR on a mannequin using a CPR recording device that records chest compression rate and depth. We will follow up with the family members at 3 months, 6 months and 12 months to see if they retained their CPR knowledge and skills and to see if they had been in a situation where their CPR skills were needed and assess whether they performed their skills or not. We will also measure the number of people with whom the subjects shared their CPR Anytime kits—a quantity known as the multiplier effect to determine if they had shared the CPR Anytime kit with their family and friends, thereby increasing the possible number of lay persons trained in CPR and in turn able to perform bystander CPR if needed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Family member's of patients with known coronary disease or cardiovascular risk factors, such as history of diabetes and hypertension.

Exclusion Criteria:

  • If someone is physically unable to undergo CPR Training
  • Someone who has received CPR training in the past 2 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01260441

Locations
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
Sponsors and Collaborators
University of Pennsylvania
American Heart Association
Investigators
Principal Investigator: Benjamin S Abella, MD, MPhil University of Pennsylvania
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Benjamin S. Abella, MD, MPhil, Clinical Research Director, Center for Resuscitation Science, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01260441     History of Changes
Other Study ID Numbers: CRS-807120
Study First Received: November 29, 2010
Last Updated: December 13, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Heart Arrest
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on May 22, 2013