Cardiac ArrestPhase 1NCT01260441
An In-Hospital Family Member Cardiopulmonary Resuscitation (CPR) Education Program
A Phase 1 study testing CPR Training using the Family and Friends CPR Anytime VSI Kit in people with Cardiac Arrest and Coronary Disease, run by University of Pennsylvania at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest, Coronary Disease, Cardiovascular Risk Factors
- What is being tested?
- CPR Training using the Family and Friends CPR Anytime VSI Kit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2007to Oct 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Family member's of patients with known coronary disease or cardiovascular risk factors, such as history of diabetes and hypertension.
Who cannot join
- If someone is physically unable to undergo CPR Training
- Someone who has received CPR training in the past 2 years
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19106
About this study
Official title: 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.
Read the 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.
- Being tested
- CPR Training using the Family and Friends CPR Anytime VSI Kit
- Medical subject headings
- Heart Arrest, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPR Training using the Family and Friends CPR Anytime VSI KitOther
Also called Family and Friends CPR Anytime, American Heart Association Family and Friends CPR Anytime, CPR Anytime Video Self Instruction (VSI)
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard CPR | Active comparator | 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 Receives: Other: CPR Training using the Family and Friends CPR Anytime VSI Kit |
| Chest Compressions Only CPR | Active comparator | 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 Receives: Other: CPR Training using the Family and Friends CPR Anytime VSI Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Self-Confidence
We will administer a comprehensive post-training likert scale scoring survey to measure the subject's comfort level using their newly acquired CPR skills.
Measured: within 30 minutes of CPR training
Secondary Training
In addition, we will administer a telephone survey to measure the subject's secondary training through the CPR Anytime Kit.
Measured: 3 month increments over a 12 month period of time
Secondary outcomes (1)
Assessing CPR Skills
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.
Measured: 3 to 6 months post-training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startOct 2007
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Benjamin S Abella, MD, MPhil, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260441
- Sponsor's protocol ID
- CRS-807120
- Status last verified
- Oct 2018
- First submitted
- 29 Nov 2010
- Last updated
- 1 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Blewer AL, Leary M, Esposito EC, Gonzalez M, Riegel B, Bobrow BJ, Abella BS. Continuous chest compression cardiopulmonary resuscitation training promotes rescuer self-confidence and increased secondary training: a hospital-based randomized controlled trial*. Crit Care Med. 2012 Mar;40(3):787-92. doi: 10.1097/CCM.0b013e318236f2ca.
PubMed 22080629
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CPR Education of Patient Family Members Using CPR Anytime Training Program
- ClinicalTrials.gov ID
- NCT01260441
- Acronym / sponsor ID
- CRS-807120
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Oct 2007
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 15 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard CPR | Active comparator | Other: CPR Training using the Family and Friends CPR Anytime VSI KitIndividuals 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 |
| Chest Compressions Only CPR | Active comparator | Other: CPR Training using the Family and Friends CPR Anytime VSI KitIndividuals 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Family member's of patients with known coronary disease or cardiovascular risk factors, such as history of diabetes and hypertension.
Key exclusion criteria (2 listed)
- If someone is physically unable to undergo CPR Training
- Someone who has received CPR training in the past 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPR Training using the Family and Friends CPR Anytime VSI KitAlso: Family and Friends CPR Anytime, American Heart Association Family and Friends CPR Anytime, CPR Anytime Video Self Instruction (VSI)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 | Chest Compressions Only CPR, Standard CPR |
Primary outcome
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.
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.
1 secondary outcome
Assessing CPR Skills
Time frame: 3 to 6 months post-training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
- Derived from this study: PubMed 22080629Blewer AL, Leary M, Esposito EC, Gonzalez M, Riegel B, Bobrow BJ, Abella BS. Continuous chest compression cardiopulmonary resuscitation training promotes rescuer self-confidence and increased secondary training: a hospital-based randomized controlled trial*. Crit Care Med. 2012 Mar;40(3):787-92. doi: 10.1097/CCM.0b013e318236f2ca.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin S Abella, MD, MPhil principal investigator
University of Pennsylvania
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CPR Training using the Family and Friends CPR Anytime VSI Kit in people with Cardiac Arrest and Coronary Disease, run by University of Pennsylvania at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject Self-Confidence (time frame: within 30 minutes of CPR training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01260441, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2018.