Team-based Implementation of Hypertension Management in Childhood Lupus (ABOUT TIME)
2026년 8월 25일 업데이트: 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.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (추정된)
등록
1200
단계
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
4
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: 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.
|
|
활성 비교기: Team Charter with Performance Monitoring without a Pre-Visit Worksheet
Adding only the team charter with performance monitoring intervention.
|
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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활성 비교기: 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.
|
|
활성 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Representative Reach of the Implementation Strategies
기간: 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.
기간: 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.
|
Evaluated at months 0, 6, 9, and then every 3 months through month 18.
|
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Improvement in Blood Pressure Control
기간: Evaluated at months 0, 6, 9, and then every 3 months through month 18.
|
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.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Fidelity to Dietary Sodium Counseling
기간: 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
기간: 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.
|
Months 18-42
|
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Maintenance of Intervention Reach
기간: 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.
|
Months 18-42
|
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Maintenance of Blood Pressure Control
기간: 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.
|
Months 18-42
|
|
24-hour Ambulatory Blood Pressure Control among Patients with Lupus Nephritis
기간: 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.
|
Evaluated at months 0, 6, 9, and then every 3 months through month 18.
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2027년 4월 1일
기본 완료 (추정된)
기본 완료
2028년 11월 30일
연구 완료 (추정된)
연구 완료
2030년 11월 30일
연구 등록 날짜
최초 제출
최초 제출
2026년 8월 21일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 8월 25일
처음 게시됨 (실제)
처음 게시됨
2026년 8월 28일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 8월 28일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 25일
마지막으로 확인됨
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- P00054342
- BPS-2025C1-43826 (기타 보조금/기금 번호: Patient-Centered Outcomes Research Institute)
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