Team-based Implementation of Hypertension Management in Childhood Lupus (ABOUT TIME)
2026年8月25日 更新者：Joyce Chang、Boston Children's Hospital
Comparing Implementation Strategies to Advance Cardiovascular Health in Children With Lupus
The goal of this study is to compare the effectiveness of widely used implementation strategies to promote adherence to guideline-concordant evidence-based practices for monitoring and controlling blood pressure in patients with lupus who are in pediatric care.
A total of 16 pediatric lupus care teams will be randomly assigned one or more of these implementation strategies.
The investigators will determine which strategy is better at ensuring the evidence-based practices reach all patients as intended and concurrently gather additional information about health outcomes as they pertain to children with childhood-onset lupus.
研究概览
地位
尚未招聘
条件
研究类型
介入性
注册 (估计的)
1200
阶段
- 不适用
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
- 孩子
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria for EHR Data Collection:
- ICD-10-CM or SNOMED-CT diagnosis code for SLE
- Completed a pediatric rheumatology outpatient clinical visit at a participating implementation site within 12 months of each data collection timepoint
Inclusion Criteria for the Patient Survey Group:
- Diagnosis of childhood-onset Systemic Lupus Erythematosus (cSLE)
- Must have had a pediatric rheumatology clinical visit at a participating implementation site within 12 months of each data collection timepoint
- Age 12 years or older at enrollment
Inclusion Criteria for the Caregiver Survey Group:
- Individuals at least 18 years of age
- Parent or guardian of a child with cSLE who is followed by a care team at a participating site
Inclusion Criteria for the Lupus Care Team Member Survey Group:
- Individuals at least 18 years of age
- Health care team members within a pediatric subspecialty that manages patients with cSLE at a participating site
Inclusion Criteria for the Patient Interview Group:
- Diagnosis of childhood-onset Systemic Lupus Erythematosus (cSLE)
- Completed a clinical visit in the participating site's outpatient rheumatology clinic within the 12 months prior to enrollment
- Age 12 years or older at enrollment
- Able to provide verbal assent if below age 18 years of age or verbal consent if age 18 years and older. For minors, verbal parental/guardian permission (informed consent) is required.
- Have access to a device with audio or audiovisual conferencing capabilities
Inclusion Criteria for the Caregiver Interview Group:
- Individuals 18 years old or older at enrollment
- Parent or guardian of a child with cSLE who is followed by a care team at a participating pediatric rheumatology site and has completed a clinical visit within the 12 months prior to enrollment
- Able to provide verbal informed consent prior to the interview
- Have access to a device with audio or audiovisual conferencing capabilities
Inclusion Criteria for the Lupus Care Team Member Interview Group:
- Individuals ages 18 years of age or older at enrollment
- Health care team members that are in a pediatric subspecialty clinic that manages patients with cSLE at a participating site
- Able to provide verbal informed consent prior to the interview
- Have access to a device with audio or audiovisual conferencing capabilities
Exclusion Criteria for all Interview Groups:
- Unable or without cognitive capacity to participate in an interview, as determined by the investigator(s).
- No prospective interview participants will be excluded on the basis of sex, race, ethnicity, or language preference.
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：其他
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Health Navigator without a Pre-Visit Worksheet
Adding only the health navigator engagement intervention
|
Adding a health navigator to the healthcare team to improve coordination among providers from different specialties and work closely with patients and their families.
The health navigator acts as a bridge between families and the care team by helping facilitate care coordination, ensuring patient and family voices are heard, and explaining medical information in clear language.
They also assist families with keeping track of medical appointments, connecting to local community resources, and providing extra support throughout the care process.
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有源比较器：Team Charter with Performance Monitoring without a Pre-Visit Worksheet
Adding only the team charter with performance monitoring intervention.
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Care teams will work together to build clear plans that explain everyone's goals, roles, and daily responsibilities.
The team will regularly check its performance data to see what is working well and what needs improvement.
By making small, step-by-step changes over time, the team can continuously refine its approach until it reaches its goals.
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有源比较器：Health Navigator with a Pre-Visit Worksheet
Adding both the health navigator engagement and pre-visit worksheet interventions
|
Adding a health navigator to the healthcare team to improve coordination among providers from different specialties and work closely with patients and their families.
The health navigator acts as a bridge between families and the care team by helping facilitate care coordination, ensuring patient and family voices are heard, and explaining medical information in clear language.
They also assist families with keeping track of medical appointments, connecting to local community resources, and providing extra support throughout the care process.
Care teams will give patients and families a short worksheet to fill out before their appointment.
This form helps them prepare to talk with their doctor about high blood pressure and heart disease risk.
It helps patients and caregivers feel ready to ask questions and take an active role in planning their heart health care.
|
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有源比较器：Team Charter and Performance Monitoring with a Pre-Visit Worksheet
Adding both the team charter and performance monitoring and pre-visit worksheet interventions.
|
Adding a health navigator to the healthcare team to improve coordination among providers from different specialties and work closely with patients and their families.
The health navigator acts as a bridge between families and the care team by helping facilitate care coordination, ensuring patient and family voices are heard, and explaining medical information in clear language.
They also assist families with keeping track of medical appointments, connecting to local community resources, and providing extra support throughout the care process.
Care teams will give patients and families a short worksheet to fill out before their appointment.
This form helps them prepare to talk with their doctor about high blood pressure and heart disease risk.
It helps patients and caregivers feel ready to ask questions and take an active role in planning their heart health care.
|
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 |
|---|---|---|
|
Representative Reach of the Implementation Strategies
大体时间：Evaluated at months 0, 6, 9, and then every 3 months through month 18.
|
The absolute difference in proportion of cSLE patients living in areas with low/very low child opportunity that receive evidence-based intervention components (ABPM and RAS inhibitors) vs. those living in areas with high/very high opportunity.
Child opportunity, defined as neighborhood resources and conditions that support healthy childhood development, will be measured by linking FIPS codes to the Child Opportunity Index (COI) version 3.0, a multidimensional area-level composite of 44 indicators in domains of education, physical environment and economic conditions, and categorized according to national rank.
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Evaluated at months 0, 6, 9, and then every 3 months through month 18.
|
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Fidelity: The extent to which the hypertension evaluation and management interventions are delivered as intended.
大体时间：Evaluated at months 0, 6, 9, and then every 3 months through month 18.
|
The pre-post intervention change in proportion of cSLE patients that receive core components of the hypertension evaluation and management interventions.
1) Adherence to hypertension evaluation will be measured by change in the % of SLE patients with LN or elevated BP who have an ABPM procedure code within the last year.
Elevated BP will be defined according to AAP/AHA guidelines: ≥120/80 if age ≥13 years; ≥90th%ile or 120/80 (whichever is lower) if age <13 years,17 on 2 or more occasions.
2) Adherence to pharmacologic treatment will be change in % of SLE patients with LN or elevated BP who are prescribed RAS inhibitors.
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Evaluated at months 0, 6, 9, and then every 3 months through month 18.
|
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Improvement in Blood Pressure Control
大体时间：Evaluated at months 0, 6, 9, and then every 3 months through month 18.
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The change in percentage of SLE patients that achieve target clinic BP (<130/80 if age 13 years or older; lower of <130/80 or <90th%ile if age <13) using the average of the last two clinic SBP or DBP readings on separate days for each patient (oscillometric or auscultory).
If ≥1 BP reading is taken on a single day, the daily mean will be used.
|
Evaluated at months 0, 6, 9, and then every 3 months through month 18.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Fidelity to Dietary Sodium Counseling
大体时间：Evaluated at months 0, 18, and 30.
|
The change in % of sampled patients with elevated blood pressure that report having discussed dietary sodium reduction with their care team.
|
Evaluated at months 0, 18, and 30.
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Maintenance of Intervention Fidelity
大体时间：Months 18-42
|
The change in adherence to the hypertension evaluation and management intervention at each site between month 18 and month 42.
Adherence is defined by the % of SLE patients with lupus nephritis (LN) or elevated blood pressure who have an ABPM procedure code within the last year, and the % of SLE patients with LN or elevated BP who are prescribed RAS inhibitors.
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Months 18-42
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Maintenance of Intervention Reach
大体时间：Months 18-42
|
The change in % of SLE patients who receive ambulatory blood pressure monitoring (ABPM) and renin-angiotensin system (RAS) inhibition in low/very low vs. high/very high COI between months 18 and 42.
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Months 18-42
|
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Maintenance of Blood Pressure Control
大体时间：Months 18-42
|
The change in proportion of SLE patients that maintain their target average clinic blood pressure, defined as <130/80 if age 13 years or older; lower of <130/80 or <90th%ile if age <13, between months 18 and 42.
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Months 18-42
|
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24-hour Ambulatory Blood Pressure Control among Patients with Lupus Nephritis
大体时间：Evaluated at months 0, 6, 9, and then every 3 months through month 18.
|
Based on their most recent ABPM study, defined as the change in % of patients with a most recent 24-hour mean arterial pressure (MAP) of <125/75 if age 13 years and older or the lower of <125/75 or 90th%ile if age <13 years old.
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Evaluated at months 0, 6, 9, and then every 3 months through month 18.
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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。
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 (估计的)
2027年4月1日
初级完成 (估计的)
2028年11月30日
研究完成 (估计的)
2030年11月30日
研究注册日期
首次提交
2026年8月21日
首先提交符合 QC 标准的
2026年8月25日
首次发布 (实际的)
2026年8月28日
研究记录更新
最后更新发布 (实际的)
2026年8月28日
上次提交的符合 QC 标准的更新
2026年8月25日
最后验证
2026年8月1日
更多信息
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.