- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01838161
Improving Adolescent Vaccination in Appalachian Kentucky (INSPIRE)
Project INSPIRE: Improving Adolescent Vaccination in Appalachian Kentucky
연구 개요
상세 설명
This is not an interventional study in which subject will be given a investigator drug or device.
Part I of the INSPIRE intervention development will involve formative research interviews conducted with parents of adolescents. Interview questions will focus on reticence to vaccinate children. Participants will be a convenience sample recruited through contacts in local public health departments and community nurses recruited by flyer and the research study coordinators (UK study personnel). Interview sessions will be scheduled in advance and will take approximately 30 minutes.
Part II of the INSPIRE intervention development will be evaluated in a small clinic-based pilot study using the same pre-test/post-test intervention design as in the planned (Part III) trial. For the pilot testing, the investigators will pilot the vaccination vignettes in a health department (clinical) setting with eligible parents of adolescents. Eligible parents who are coming in for non-acute care appointments will be asked by a research nurse to enroll in a research study. The Investigator will then administer a pretest survey, expose participants (parents) to vignette condition using the iPad in the clinic, and a post-test survey measuring intention to receive appropriate adolescent vaccines for their child as well as perceived message effectiveness (for the vignette). At the conclusion of the study, the research personnel administering the study will refer the adolescent to the clinic staff who will offer adolescent vaccines at the conclusion of the study (and/or a cue to schedule an appointment for the adolescent to visit the clinic) and will be able to examine actual behavior by receiving informed consent (from parents and adolescent) for limited medical record review (to track adolescent receipt of vaccinations). The Investigator will perform this pilot study in one Kentucky River Area District health department clinic with 30 parents. This method has been used to pilot past interventions, and it is expected that this allow us to correct for any problems in either the design of the survey assessment or the intervention. If needed, the investigator can tweak the intervention and re-pilot using the same procedures before the randomized controlled trial. This pilot test will also provide the advantage of assuring us that the intervention procedure can translate to the clinic setting. The Investigator has experience with this translation from our 1-2-3 Pap video intervention which the investigators began in social settings (recruiting people at school and other community events) and moved into the clinic setting for dissemination.
Part III of the INSPIRE project will be evaluated in a site-based group randomized controlled trial design, with individual-level randomization also occurring within the intervention group. Community vaccination clinic and health education sites (staffed by local health department contracted personnel and project nurses) in the intervention and control conditions will be matched on percentage of free/reduced school lunch and relevant demographics. At the end of Year 1, one health site in each pair will be randomized to the enhanced video educational intervention (video vignettes + standard of care social marketing vaccine event) or a standard of care vaccination campaign (standard of care health department vaccine event) comparison group. Individuals in the intervention group randomized condition also will be randomized when recruitment occurs in non-school based locations. Assessments will be conducted using Automated iPad Audio Assisted Interviewing techniques at pretest, immediate post-test, and then medical record review at 1 month and 9 month follow-up points. The medical record review will entail examining the medical record for each adolescent vaccine received by the patient. Thus, the investigators will be able to examine behavior change (i.e., receipt of vaccination) for each of the different vaccine types and their single or multi-dose outcomes.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Kentucky
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Lexington, Kentucky, 미국, 40536
- University of Kentucky
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Lexington, Kentucky, 미국, 40475
- University of Kentucky
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Parents/guardians with legal custody of a minor child
- Parents of children 11-18 years of age.
Exclusion Criteria:
- Parents under the age of 18
- Allergy to vaccinations
- Parent has made an informed decision not to vaccinate their child
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Part I
Interview questions will focus on reticence to vaccinate children.
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Parental Interviews
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실험적: Part II
We will pilot the vaccination vignettes in a health department (clinical) setting with eligible parents of adolescents.
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Parents will be exposed to an educational video intervention if they are enrolled in this intervention condition.
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실험적: Part III
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•video educational
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Part I - Parent Interviews
기간: 1 year
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Interview questions will focus on reticence to vaccinate children.
Participants will be a convenience sample recruited through contacts in local public health departments, community nurses and the research study coordinators.
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1 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Part II - Intention to Vaccinate
기간: 1 Year
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The investigator will pilot the vaccination vignettes in a health department (clinical) setting with eligible parents of adolescents.
The Investigator will then expose parents to vignette condition using the iPad, administer a pretest survey, the video vignette, and a post-test survey measuring intention to receive appropriate adolescent vaccines for their child as well as perceived message effectiveness (for the vignette).
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1 Year
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Part III - Site-based group randomized controlled trial design - Vaccination outcomes
기간: 1 year
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Community vaccination clinic sites in the intervention and control conditions will be matched on percentage of free/reduced school lunch and relevant demographics.
Randomization will occur at the group and individual level.
One site in each pair will be randomized to the enhanced video educational intervention condition (within this group individuals will be randomized to video vignettes + standard of care vaccine education or the standard of care vaccine education) or a standard of care (standard of care vaccine education) comparison group.
The medical record review will allow us to examine behavior change (i.e., receipt of age-appropriate vaccinations) for each of the different vaccine types and their single or multi-dose outcomes.
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1 year
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공동 작업자 및 조사자
수사관
- 수석 연구원: Elisia Cohen, PhD, University of Kentucky
간행물 및 유용한 링크
일반 간행물
- Cohen, E. L. and K. J. Head (2014).
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 (실제)
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. .
Adolescent Immunization에 대한 임상 시험
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University of RochesterCenters for Disease Control and Prevention완전한
Part I에 대한 임상 시험
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Louisiana State University Health Sciences Center...Millennium Pharmaceuticals, Inc.빼는
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Hero Institute for Infant NutritionUniversidad de Murcia; University of Valencia; Universidad de Granada완전한
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Helsinki University Central HospitalUniversity of Helsinki; Finnish Institute for Health and Welfare; Finnish Institute of Occupational...모병
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University of WuerzburgDeutsche Krebshilfe e.V., Bonn (Germany)모병
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VA Office of Research and DevelopmentVA Finger Lakes Healthcare System모병