- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03304574
CheckED Yourself Study
CheckED Yourself: Using Emergency Department Screening to Impact Adolescent Risk Behavior
연구 개요
상세 설명
Adolescents and their parents (if participant is under the age of 18 years) will be approached and invited to participate in the study during their Emergency Department (ED) visit. Following consent, adolescents will be randomized to the intervention or control group. A tablet computer will be provided to the participants for use during their baseline assessment in the ED. The CheckED Yourself App will be pre-loaded on the tablet. The CheckED Yourself App (eHA-IPF) is an innovative electronic health screening tool with integrated personalized feedback about risk behaviors. The CheckED Yourself App (eHA-IPF) will be divided into an assessment about risk behaviors and a personalized feedback portion. Participants will be randomized to a control or intervention group at the time of consent. Those in the intervention group will receive both parts of the CheckED Yourself App, while the control group will receive only the assessment with no feedback.
Those in the Intervention arm will complete the health risk behavior assessment and receive integrated personalized feedback from the CheckED Yourself App (eHA-IPF), and those in the control group will complete the health risk behavior assessment only. Participants will complete the questionnaire at some point during their ED visit and prior to discharge.
Follow-up assessments will be completed at 1-day and 3 months post ED visit via an online survey. Reminders for the 1-day and 3-month follow-ups will be sent via email or text message. The 1-day assessment will focus on adolescent-reported motivation to make a health behavior change, the content of the ED visit including what, if any, risk behaviors their ED provider discussed with the participant, and satisfaction with care in the ED. The 3-month assessment will include a re-assessment of risk behaviors.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Washington
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Seattle, Washington, 미국, 98105
- 모병
- Seattle Children's Hospital
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연락하다:
- Lindsey Johnson
- 전화번호: 206-884-1075
- 이메일: lindsey.johnson@seattlechildrens.org
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수석 연구원:
- Taraneh Shafii, MD, MPH
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부수사관:
- Eileen Klein, MD, MPH
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부수사관:
- Siobhan Thomas-Smith, MD
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부수사관:
- Stephanie Richling, MD
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부수사관:
- Laura Richardson, MD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 13-18 years of age
- Ability of patient and parent of patient <18 years old to fluently speak and read English
- Has email address and/or cell phone
Exclusion Criteria:
- Inability to independently complete the assessment due to intellectual disability
- Acute cognitive impairment due to injury and/or intoxication
- Administration of IV sedation or pain medications during Emergency Department visit
- Presenting to the Emergency Department due to a psychiatric or mental health complaint
- Emergency Department visit results in hospital admission
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: Control
Participants will complete the electronic health assessment only and will not receive integrated personalized feedback
|
|
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실험적: Intervention
Participants will complete the electronic health assessment and will receive integrated personalized feedback
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Integrated personalized feedback about self-reported risk behaviors will be generated and shown to participants as they complete their baseline health risk assessment using the CheckED Yourself app.
The integrated personalized feedback is based on motivational feedback strategies such as normative feedback (comparison to peer behaviors and age-based health guidelines), increasing knowledge regarding potential consequences of behaviors, and providing practical tips for changing behavior.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Motivation to change
기간: We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.
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To evaluate if adolescents who received integrated personalized feedback had higher levels of motivation to change their risk behaviors post-Emergency Department visit compared to adolescents who completed the electronic health assessment only and did not receive personalized feedback
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We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.
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Decreased risk behaviors
기간: We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.
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To evaluate if adolescents who received integrated personalized feedback reported decreased risk behaviors 3 months post-Emergency Department visit compared to adolescents who completed the electronic health assessment only and did not receive personalized feedback.
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We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.
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Prevalence of risk behaviors
기간: We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.
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To describe the prevalence of risk behaviors among adolescents who present to the Emergency Department for care.
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We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 00000365
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
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