CPR Training in 7th Grade Students
| Tracking Information | |||||
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| First Received Date ICMJE | December 10, 2007 | ||||
| Last Updated Date | April 25, 2012 | ||||
| Start Date ICMJE | January 2008 | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00570609 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | CPR Training in 7th Grade Students | ||||
| Official Title ICMJE | CPR Training in 7th Grade Students | ||||
| Brief 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. 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:
Research Hypothesis:
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Other: CPR Anytime education
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 |
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| Study Arm (s) | Experimental: CPR Anytime
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
Intervention: Other: CPR Anytime education |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 8 | ||||
| Completion Date | June 2010 | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00570609 | ||||
| Other Study ID Numbers ICMJE | 2-20070909 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Marna Rayl Greenberg, Lehigh Valley Hospital | ||||
| Study Sponsor ICMJE | Marna Rayl Greenberg | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Lehigh Valley Hospital | ||||
| Verification Date | April 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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