Prevention of Sudden DeathNCT00570947
CPR Prescription Program
A study testing CPR Anytime Kit in people with Prevention of Sudden Death, run by Lehigh Valley Hospital.
Trial summary
In this study we hope to show that prescriptions provided for CPR Anytime™ to patients who are at risk for or have heart disease at three key locations, can motivate families to learn the skill. We will use our ED sites, an office based primary care setting, and an office based cardiology practice. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Prevention of Sudden Death
- What is being tested?
- CPR Anytime Kit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- Dec 2007to Jul 2009
- Phase
- Interventional
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking
- 45 or older
- Competent outpatient.
- Have DVD access in home.
- Willing to fill prescriptions at Spectrum pharmacy.
- Never had CPR, or CPR greater than 1 year ago.
- Have a risk factor for heart disease or have heart disease.
Who cannot join
- Non English speaking
- Minors
- Incompetent or significantly ill/distressed
- No DVD access
- Unwilling to fill rx at spectrum.
- CPR less than 1 year ago.
About this study
In this study we hope to show that prescriptions provided for CPR Anytime™ to patients who are at risk for or have heart disease at three key locations, can motivate families to learn the skill. We will use our ED sites, an office based primary care setting, and an office based cardiology practice. Participants will be given the pharmacy locations where they can be purchased. Optimally they will complete the program at home with their family.
Research Hypothesis:
- Families of patients at risk for coronary artery disease can be motivated to learn CPR by receiving a prescription for a CPR Anytime ™ self learning kit.
- As part of the multiplier effect, an additional 1.5 family members per participant are projected to be trained to perform CPR.
- Families may experience a "teachable moment" when their loved one is in the emergency department. In comparison to the office settings, this may increase the likelihood that they fill the prescription for CPR Anytime® and complete the learning kit.
Read the detailed description
This will be a prospective study of patients presenting to one of three recruiting sites (emergency department and office based primary care/cardiology settings). Physicians at all settings will agree to be a part of the Physician CPR Prescription program. Participating physicians are provided with a description of the Physician CPR Prescription program and pre-printed CPR prescription pads. The front side of the prescription is preprinted with the information needed to obtain CPR Anytime ™ for Friends and Family. The back of the prescription is preprinted with "Quick Facts" to assist the physician in delivering a consistent and persuasive CPR message to patients and their families.
After consent, participants will be randomized to one of two groups. The control group will be advised to take a traditional CPR class and be offered a list of local classes. Phone follow up at approximately 3 months will assess their participation. The study group will be asked to fill the CPR Anytime ™ prescription and complete the program. They will be encouraged to include other friends and family members in the program. Follow up phone survey at approximately three months will assess compliance with physician recommendations to fill the prescription, as well as actual completion of the materials (and possible multiplier effect).
Comparisons between the sites regarding efficacy of prescribing will be performed. Results will be reported as mean +/- standard deviation, % or frequencies to summarize patient characteristics. One way ANOVA will be used to compare the three groups for continuous data and chi-square for categorical data.
- Conditions
- Prevention of Sudden Death
- Being tested
- CPR Anytime Kit
- Keywords
- CPR Anytime
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPR Anytime KitOther
The study group will be asked to fill the CPR Anytime ™ prescription and complete the program. They will be encouraged to include other friends and family members in the program
| Study group | Role | What they receive |
|---|---|---|
| Class | Active comparator | The control group will be advised to take a traditional CPR class and be offered a list of local classes. Receives: Other: CPR Anytime Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of CPR
Measured: 3 months
Secondary outcomes (1)
Family Member completion of CPR
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Sudden DeathStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lehigh Valley Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marna Rayl Greenberg, Lehigh Valley Hospital
- Investigators
- Marna R Greenberg, D.O., Principal investigator, LVH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570947
- Sponsor's protocol ID
- 2-20070910
- Status last verified
- Apr 2012
- First submitted
- 10 Dec 2007
- Last updated
- 26 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CPR Prescription Program
- ClinicalTrials.gov ID
- NCT00570947
- Acronym / sponsor ID
- 2-20070910
- Conditions
- Prevention of Sudden Death
- Keywords
- CPR Anytime
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Lehigh Valley HospitalUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 11 Dec 2007 (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.
In this study we hope to show that prescriptions provided for CPR Anytime™ to patients who are at risk for or have heart disease at three key locations, can motivate families to learn the skill. We will use our ED sites, an office based primary care setting, and an office based cardiology practice. Participants will be given the pharmacy locations where they can be purchased. Optimally they will complete the program at home with their family.
Research Hypothesis:
- Families of patients at risk for coronary artery disease can be motivated to learn CPR by receiving a prescription for a CPR Anytime ™ self learning kit.
- As part of the multiplier effect, an additional 1.5 family members per participant are projected to be trained to perform CPR.
- Families may experience a "teachable moment" when their loved one is in the emergency department. In comparison to the office settings, this may increase the likelihood that they fill the prescription for CPR Anytime® and complete the learning kit.
Detailed description
This will be a prospective study of patients presenting to one of three recruiting sites (emergency department and office based primary care/cardiology settings). Physicians at all settings will agree to be a part of the Physician CPR Prescription program. Participating physicians are provided with a description of the Physician CPR Prescription program and pre-printed CPR prescription pads. The front side of the prescription is preprinted with the information needed to obtain CPR Anytime ™ for Friends and Family. The back of the prescription is preprinted with "Quick Facts" to assist the physician in delivering a consistent and persuasive CPR message to patients and their families.
After consent, participants will be randomized to one of two groups. The control group will be advised to take a traditional CPR class and be offered a list of local classes. Phone follow up at approximately 3 months will assess their participation. The study group will be asked to fill the CPR Anytime ™ prescription and complete the program. They will be encouraged to include other friends and family members in the program. Follow up phone survey at approximately three months will assess compliance with physician recommendations to fill the prescription, as well as actual completion of the materials (and possible multiplier effect).
Comparisons between the sites regarding efficacy of prescribing will be performed. Results will be reported as mean +/- standard deviation, % or frequencies to summarize patient characteristics. One way ANOVA will be used to compare the three groups for continuous data and chi-square for categorical data.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Class | Active comparator | Other: CPR Anytime KitThe control group will be advised to take a traditional CPR class and be offered a list of local classes. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- English speaking
- 45 or older
- Competent outpatient.
- Have DVD access in home.
- Willing to fill prescriptions at Spectrum pharmacy.
Key exclusion criteria (6 listed)
- Non English speaking
- Minors
- Incompetent or significantly ill/distressed
- No DVD access
- Unwilling to fill rx at spectrum.
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 Anytime KitThe study group will be asked to fill the CPR Anytime ™ prescription and complete the program. They will be encouraged to include other friends and family members in the program | Other | Class |
Primary outcome
Completion of CPR
Time frame: 3 months
1 secondary outcome
Family Member completion of CPR
Time frame: 3 months
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 26 Apr 2012.
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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.
Marna R Greenberg, D.O. principal investigator
LVH
Questions about this trial
What is this clinical trial studying?
A study testing CPR Anytime Kit in people with Prevention of Sudden Death, run by Lehigh Valley Hospital.
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 7 inclusion and 6 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 26 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Completion of CPR (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2012.