- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00570609
CPR Training in 7th Grade Students
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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Pennsylvania
-
Allentown, Pennsylvania, 미국, 18103
- Salisbury Middle School
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Participants
- Access to home DVD player
- Participants must be able to read, speak and understand English
Exclusion Criteria:Exclusion Criteria:
- Lack of functioning home DVD player
- Physical limitation to the ability to perform CPR/Chest compressions
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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
|
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
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
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®,
기간: 6 months
|
6 months
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
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
기간: 6 months
|
6 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Marna R Greenberg, D.O., MPH, LVH
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
관상 동맥 경화증에 대한 임상 시험
-
Chinese Academy of Medical Sciences, Fuwai HospitalMedtronic; CCRF Consulting Co., Ltd.빼는Transradial-transfemoral Coronary Interventions 비교
-
CCRF Consulting Co., Ltd.Peking University First Hospital; Terumo Medical(shanghai) Co.,Ltd.알려지지 않은심장 또는 뇌혈관 질환 무료 요금 | Transradial-transfemoral Coronary Interventions 비교중국
-
Hospital Clinic of BarcelonaAstraZeneca완전한CTO(Chronic Total Occlusion)를 위한 PCI(Percutaneous Coronary Intervention)를 받을 예정인 환자스페인
CPR Anytime education에 대한 임상 시험
-
University of PennsylvaniaAmerican Heart Association완전한
-
University of PennsylvaniaPatient-Centered Outcomes Research Institute완전한
-
Seoul National University Hospital종료됨
-
Chia-Tzu Line완전한