Coronary AtherosclerosisNCT00570609
CPR Training in 7th Grade Students
A study testing CPR Anytime education in people with Coronary Atherosclerosis and Prevention of Heart Disease, run by Marna Rayl Greenberg at 1 site in United States.
Trial summary
This is a prospective study of 7th grade students participating in the CPR Anytime® program. After consent, participants will be asked to complete the program with their parent(s)/legal guardian(s) and encouraged to include other friends and family members in the program. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Atherosclerosis, Prevention of Heart Disease
- What is being tested?
- CPR Anytime education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jun 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants
- Access to home DVD player
- Participants must be able to read, speak and understand English
Who cannot join
- Lack of functioning home DVD player
- Physical limitation to the ability to perform CPR/Chest compressions
Trial locations and contacts
1 site in 1 country.
United States1 site
Salisbury Middle School
Allentown, Pennsylvania, 18103
About this study
This is a prospective study of 7th grade students participating in the CPR Anytime® program. After consent, participants will be asked to complete the program with their parent(s)/legal guardian(s) and encouraged to include other friends and family members in the program. After completing the program, the participant and their parent(s) will be evaluated for adequacy of chest compressions/CPR. The student participants will be evaluated again at 6 months for adequacy of chest compressions/CPR
Objectives:
Read more
- To evaluate 7th grade students for adequacy of CPR and chest compressions after completing a take home CPR course
- To evaluate the multiplier effect of students training in CPR with their parents/family members using a take home CPR instructional kit
- To evaluate the participating parent for adequacy of CPR and chest compressions after completing a take home CPR course
Research Hypothesis:
- 7th grade students can be trained, using CPR Anytime®, to perform adequate chest compressions/CPR and their skills will be maintained at 6 months
- As part of the multiplier effect, an additional 1.5 family members per participant will be trained to perform adequate chest compressions/CPR
Read the detailed description
Participants will be selected from Salisbury and Swain schools. Parents and students from the participating schools will be invited by the school to an educational assembly in the fall of 2007. The material covered in the assembly will include issues of heart health and the importance of CPR. At the conclusion of the educational session, a description of the proposed study will be presented. The description will include details of the study and consent process. The consent and assent will be explained in detail to the prospective participants. The description of the study and consent/assent process will be delivered by one of the study investigators/coordinators. Details of the consent/assent will also be given to the prospective participants in a written format
For those potential participants unable to attend the assembly, consent and assent forms will be sent home with the student. Description of the project and explanation of the assent/consent process will be included. The potential participants will be encouraged to contact a study team member should they have any questions relating to the project or assent/consent process. Potential participants will be asked to return to the school on the projected date of CPR evaluations. The study team members will have the opportunity during this meeting to explain the study procedures as well as obtaining assent/consent.
After obtaining consent/assent, participants will be given a CPR Anytime kit and asked to complete the training at home with their parent(s)/guardian(s). They will also be encouraged to invite other family members and friends to participate with them in the training. All students in the 7th grade whether they participate in the study or not at the respective schools will receive a CPR Anytime kit.
The kit consists of a portable inflatable CPR training mannequin, a CPR training booklet, a 22 minute training DVD, and cleaning towelettes.
After completing the training, the student and parent participants will be evaluated for quality of CPR/chest compressions by a trained CPR instructor. The evaluation will be done on an individual basis not as a group. If remediation is required, it will take place at the time of the evaluation. The evaluation will be done at the school. The student participant will return at approximately months for reevaluation by the CPR instructor.
The student and parent participants will be asked to complete a survey at the time of initial training. The student participant will be asked to complete a follow up survey at the 3 month follow up
The data collected will be entered into a database. Each participant will be given a study identification number and data will be entered into the database using that number. The surveys will be anonymous. The participants will be identified by name on the CPR evaluations. Those families who receive the CPR Anytime kit but do not participate in the research study for testing will be surveyed to see how they used the kit in their home.
All hard copies (surveys and evaluation forms ) will be destroyed immediately after the data has been entered into the database. Access to the data will be limited to the PI and study coordinators. The hard copies and database will be stored in the research office and the office will be locked when not in use.
- Being tested
- CPR Anytime education
- Keywords
- CPR
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPR Anytime educationOther
After consent, participants will be asked to complete the 22 minute DVD CPR Anytime program with their parent(s)/legal guardian(s) and encouraged to include other friends and family members in the program
| Study group | Role | What they receive |
|---|---|---|
| CPR Anytime | Experimental | Participants will be asked to complete the program with their parent(s)/legal guardian(s) and encouraged to include other friends and family members in the program Receives: Other: CPR Anytime education |
What is being measured
The primary outcome is the main question the study is designed to answer.
As tested by a CPR instructor, 7th grade students will be evaluated for performance of adequate chest compressions/CPR initially and at at 6 months after training with CPR Anytime®,
Measured: 6 months
Secondary outcomes (1)
As part of the multiplier effect, an additional 1.5 family members per participant will be expected to be trained to perform adequate chest compressions/CPR
Measured: 6 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 startJan 2008
- Primary completionDec 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary AtherosclerosisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marna Rayl Greenberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marna Rayl Greenberg, Lehigh Valley Hospital
- Investigators
- Marna R Greenberg, D.O., MPH, Principal investigator, LVH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570609
- Sponsor's protocol ID
- 2-20070909
- 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 Training in 7th Grade Students
- ClinicalTrials.gov ID
- NCT00570609
- Acronym / sponsor ID
- 2-20070909
- Keywords
- CPR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Marna Rayl GreenbergUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2010 (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.
This is a prospective study of 7th grade students participating in the CPR Anytime® program. After consent, participants will be asked to complete the program with their parent(s)/legal guardian(s) and encouraged to include other friends and family members in the program. After completing the program, the participant and their parent(s) will be evaluated for adequacy of chest compressions/CPR. The student participants will be evaluated again at 6 months for adequacy of chest compressions/CPR
Objectives:
- To evaluate 7th grade students for adequacy of CPR and chest compressions after completing a take home CPR course
- To evaluate the multiplier effect of students training in CPR with their parents/family members using a take home CPR instructional kit
- To evaluate the participating parent for adequacy of CPR and chest compressions after completing a take home CPR course
Research Hypothesis:
- 7th grade students can be trained, using CPR Anytime®, to perform adequate chest compressions/CPR and their skills will be maintained at 6 months
- As part of the multiplier effect, an additional 1.5 family members per participant will be trained to perform adequate chest compressions/CPR
Detailed description
Participants will be selected from Salisbury and Swain schools. Parents and students from the participating schools will be invited by the school to an educational assembly in the fall of 2007. The material covered in the assembly will include issues of heart health and the importance of CPR. At the conclusion of the educational session, a description of the proposed study will be presented. The description will include details of the study and consent process. The consent and assent will be explained in detail to the prospective participants. The description of the study and consent/assent process will be delivered by one of the study investigators/coordinators. Details of the consent/assent will also be given to the prospective participants in a written format
For those potential participants unable to attend the assembly, consent and assent forms will be sent home with the student. Description of the project and explanation of the assent/consent process will be included. The potential participants will be encouraged to contact a study team member should they have any questions relating to the project or assent/consent process. Potential participants will be asked to return to the school on the projected date of CPR evaluations. The study team members will have the opportunity during this meeting to explain the study procedures as well as obtaining assent/consent.
After obtaining consent/assent, participants will be given a CPR Anytime kit and asked to complete the training at home with their parent(s)/guardian(s). They will also be encouraged to invite other family members and friends to participate with them in the training. All students in the 7th grade whether they participate in the study or not at the respective schools will receive a CPR Anytime kit.
The kit consists of a portable inflatable CPR training mannequin, a CPR training booklet, a 22 minute training DVD, and cleaning towelettes.
After completing the training, the student and parent participants will be evaluated for quality of CPR/chest compressions by a trained CPR instructor. The evaluation will be done on an individual basis not as a group. If remediation is required, it will take place at the time of the evaluation. The evaluation will be done at the school. The student participant will return at approximately months for reevaluation by the CPR instructor.
The student and parent participants will be asked to complete a survey at the time of initial training. The student participant will be asked to complete a follow up survey at the 3 month follow up
The data collected will be entered into a database. Each participant will be given a study identification number and data will be entered into the database using that number. The surveys will be anonymous. The participants will be identified by name on the CPR evaluations. Those families who receive the CPR Anytime kit but do not participate in the research study for testing will be surveyed to see how they used the kit in their home.
All hard copies (surveys and evaluation forms ) will be destroyed immediately after the data has been entered into the database. Access to the data will be limited to the PI and study coordinators. The hard copies and database will be stored in the research office and the office will be locked when not in use.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPR Anytime | Experimental | Other: CPR Anytime educationParticipants will be asked to complete the program with their parent(s)/legal guardian(s) and encouraged to include other friends and family members in the program |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Participants
- Access to home DVD player
- Participants must be able to read, speak and understand English
Key exclusion criteria (2 listed)
- Lack of functioning home DVD player
- Physical limitation to the ability to perform CPR/Chest compressions
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 educationAfter consent, participants will be asked to complete the 22 minute DVD CPR Anytime program with their parent(s)/legal guardian(s) and encouraged to include other friends and family members in the program | Other | CPR Anytime |
Primary outcome
As tested by a CPR instructor, 7th grade students will be evaluated for performance of adequate chest compressions/CPR initially and at at 6 months after training with CPR Anytime®,
Time frame: 6 months
1 secondary outcome
As part of the multiplier effect, an additional 1.5 family members per participant will be expected to be trained to perform adequate chest compressions/CPR
Time frame: 6 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., MPH principal investigator
LVH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPR Anytime education in people with Coronary Atherosclerosis and Prevention of Heart Disease, run by Marna Rayl Greenberg at 1 site 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 3 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 26 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
As tested by a CPR instructor, 7th grade students will be evaluated for performance of adequate chest compressions/CPR initially and at at 6 months after training with CPR Anytime®, (time frame: 6 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.