Using Health Information Technology to Improve Health Behaviors and Promote Cardiovascular Health Among Adolescent and Young Adult Cancer Survivors
2022年8月24日 更新者：Washington University School of Medicine
Health information technology (HIT) has the potential to improve the quality, efficiency, consistency, and availability of cancer survivor care.
PREVENT is a novel HIT tool designed by our team for adolescents (12-19 years).
PREVENT aggregates and displays the American Heart Association's (AHA) Life Simple 7 cardiovascular health (CVH) risk factors and provides tailored, evidence-based, behavior change recommendations inclusive of community resources that are delivered to overweight/obese adolescents at the point-of-care to improve CVH.
The investigators seek to expand this tool for patients beyond 19 years of age to increase this tool's reach to the entire adolescent and young adult (AYA) age range and then evaluate its effectiveness among AYA cancer survivors.
研究概览
研究类型
介入性
注册 (实际的)
26
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Missouri
-
Saint Louis、Missouri、美国、63110
- Washington University School of Medicine
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 39年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Patient eligibility criteria
- Aged 20-39 years
- Prior diagnosis of pediatric cancer (diagnosed <21 years of age).
- Not receiving active therapy for their cancer
- Receiving care from the Pediatric Hematology/Oncology staff and physicians at St. Louis Children's Hospital, the St. Louis Children's Specialty Care Center, Siteman Cancer Center's Lifelong Outcomes Clinic at Siteman South County
- At risk for poor CVH (BMI ≥ 25 kg/m^2)
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Provider eligibility criteria.
-All providers and clinic staff (physicians, nurses, clinic staff, clinic research associates) in the Pediatric Hematology/Oncology program at St. Louis Children's Hospital and the CSCC or in the Siteman Cancer Center's Lifelong Outcomes Clinic at Siteman South County are eligible to participate.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Providers
-All eligible providers will be sent questionnaires electronically to their email at baseline and follow-up.
Providers will be invited to attend a training session to educate them on the PREVENT tool at baseline.
The providers will be delivering the PREVENT tool.
|
-PREVENT is a novel Health Information Technology tool designed to promote physical activity and healthy food intake among overweight/obese patients at the point of care.
PREVENT automates the delivery of personalized, evidence-based behavior change recommendations and provides an interactive map of community resources to help providers link patients to resources in their community.
|
|
有源比较器：Patients - Wait-List Control
|
-Will receive routine clinical care.
After completion of follow-up measures, control participants will receive a behavior change prescription via the PREVENT tool
|
|
实验性的：Patients - PREVENT Tool
|
-PREVENT is a novel Health Information Technology tool designed to promote physical activity and healthy food intake among overweight/obese patients at the point of care.
PREVENT automates the delivery of personalized, evidence-based behavior change recommendations and provides an interactive map of community resources to help providers link patients to resources in their community.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
食物摄入行为的改变
大体时间：在基线和 3 个月
|
使用简短的健康行为和态度调查收集患者报告的食物摄入行为（水果和蔬菜摄入、全谷物、含糖饮料和零食行为）。
|
在基线和 3 个月
|
|
Change in minutes of physical activity
大体时间：At baseline and 3-months
|
Physical activity will be measured using a triaxial accelerometer (Actigraph GT3X+, Actigraph of Ft.
Walton Beach, FL).
The participant will be instructed to wear the accelerometer on an elasticized belt, on the left mid-axillary line.
The Actigraph is one of the most common accelerometers used for scientific purposes.
Participants will be encouraged to wear the accelerometer 24-hours per day for at least 7-days, including 2 weekend days.
|
At baseline and 3-months
|
|
Change in body mass index (BMI)
大体时间：At baseline and 3-months
|
Collected from patient's medical record.
|
At baseline and 3-months
|
|
Change on patient's attitudes toward behavior change
大体时间：At baseline and 3-months
|
A survey (6-question) administered to patients will assess attitudes toward and readiness for behavior change.
Questions are asked using a 5-point Likert scale (range: 0-30) with a higher score indicating more positive attitudes.
|
At baseline and 3-months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
提供者对 PREVENT 工具的满意度：调查
大体时间：3个月
|
一项调查（15 个问题）将评估提供者对健康信息技术五个方面的满意度：内容、准确性、格式、易用性和及时性。
问题采用 5 分李克特量表（范围：15-75）提出，分数越高表示满意度越高
|
3个月
|
|
Change in patients' satisfaction of PREVENT tool: survey
大体时间：Within 48 hours of clinic visit and at 3-months
|
Within 48 hours of clinic visit and at 3-months
|
|
|
Change on patient's average systolic and diastolic blood pressure
大体时间：At baseline and 3-months
|
Collected from patient's medical record
|
At baseline and 3-months
|
|
Change in patient's cholesterol
大体时间：At baseline and 3-months
|
Collected from patient's medical record
|
At baseline and 3-months
|
|
Change in patient's fasting blood glucose
大体时间：At baseline and 3-months
|
Collected from patient's medical record
|
At baseline and 3-months
|
|
Provider's motivation for sustained use of PREVENT tool
大体时间：3-months
|
-A survey (12-questions) will assess provider's intent to change their behavior and continue using PREVENT were adapted from Legare's CPD Reaction Questionnaire.
Questions are asked using a 7-point Likert scale (range: 12-84) with a higher score indicating greater motivation for sustained use.
|
3-months
|
|
Fidelity of PREVENT tool implementation
大体时间：0-3 months
|
-Fidelity will be measured using direct observation of patient-provider interactions while using the PREVENT tool.
A direct observation checklist will be used by the observer to determine the number of interactions with the PREVENT tool that were implemented as intended.
|
0-3 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年6月23日
初级完成 (实际的)
2022年3月25日
研究完成 (实际的)
2022年3月25日
研究注册日期
首次提交
2020年11月2日
首先提交符合 QC 标准的
2020年11月3日
首次发布 (实际的)
2020年11月10日
研究记录更新
最后更新发布 (实际的)
2022年8月25日
上次提交的符合 QC 标准的更新
2022年8月24日
最后验证
2022年8月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 202011075
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
PREVENT tool的临床试验
-
Weill Medical College of Cornell UniversityNational Institute of Mental Health (NIMH)招聘中