- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01260441
An In-Hospital Family Member Cardiopulmonary Resuscitation (CPR) Education Program
October 31, 2018 updated by: University of Pennsylvania
CPR Education of Patient Family Members Using CPR Anytime Training Program
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
500
Phase
- Phase 1
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
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Penn Presbyterian Medical Center
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Philadelphia, Pennsylvania, United States, 19106
- Pennsylvania Hospital
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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
Yes
Genders Eligible for Study
All
Description
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
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
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:
|
|
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
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subject Self-Confidence
Time Frame: within 30 minutes of CPR training
|
We will administer a comprehensive post-training likert scale scoring survey to measure the subject's comfort level using their newly acquired CPR skills.
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within 30 minutes of CPR training
|
|
Secondary Training
Time Frame: 3 month increments over a 12 month period of time
|
In addition, we will administer a telephone survey to measure the subject's secondary training through the CPR Anytime Kit.
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3 month increments over a 12 month period of time
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessing CPR Skills
Time Frame: 3 to 6 months post-training
|
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.
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3 to 6 months post-training
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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.
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
October 1, 2007
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
November 29, 2010
First Submitted That Met QC Criteria
December 13, 2010
First Posted (Estimate)
December 15, 2010
Study Record Updates
Last Update Posted (Actual)
November 1, 2018
Last Update Submitted That Met QC Criteria
October 31, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRS-807120
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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