Systemic Lupus Erthematosus (SLE)ABOUT TIMENCT07792733
Team-based Implementation of Hypertension Management in Childhood Lupus
A study testing Health Navigator Engagement, Team Charter with Performance Monitoring and Pre-visit worksheet in people with Systemic Lupus Erthematosus (SLE), run by Boston Children's Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Systemic Lupus Erthematosus (SLE)
- What is being tested?
- Health Navigator Engagement, Team Charter with Performance Monitoring and Pre-visit worksheet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Apr 2027to 30 Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
- 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
- Individuals at least 18 years of age
Show all 24Show fewer
- 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
- 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
- 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
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Systemic Lupus Erthematosus (SLE)
- Being tested
- Health Navigator Engagement, Team Charter with Performance Monitoring, Pre-visit worksheet
- Keywords
- lupus, SLE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Navigator EngagementOther
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.
Team Charter with Performance MonitoringOther
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.
Pre-visit worksheetOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Health Navigator without a Pre-Visit Worksheet | Active comparator | Adding only the health navigator engagement intervention Receives: Other: Health Navigator Engagement |
| Team Charter with Performance Monitoring without a Pre-Visit Worksheet | Active comparator | Adding only the team charter with performance monitoring intervention. Receives: Other: Team Charter with Performance Monitoring |
| Health Navigator with a Pre-Visit Worksheet | Active comparator | Adding both the health navigator engagement and pre-visit worksheet interventions Receives: Other: Health Navigator Engagement; Other: Pre-visit worksheet |
| Team Charter and Performance Monitoring with a Pre-Visit Worksheet | Active comparator | Adding both the team charter and performance monitoring and pre-visit worksheet interventions. Receives: Other: Health Navigator Engagement; Other: Pre-visit worksheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Representative Reach of the Implementation Strategies
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.
Measured: Evaluated at months 0, 6, 9, and then every 3 months through month 18.
Fidelity: The extent to which the hypertension evaluation and management interventions are delivered as intended.
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.
Measured: Evaluated at months 0, 6, 9, and then every 3 months through month 18.
Improvement in Blood Pressure Control
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.
Measured: Evaluated at months 0, 6, 9, and then every 3 months through month 18.
Secondary outcomes (5)
Fidelity to Dietary Sodium Counseling
The change in % of sampled patients with elevated blood pressure that report having discussed dietary sodium reduction with their care team.
Measured: Evaluated at months 0, 18, and 30.
Maintenance of Intervention Fidelity
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.
Measured: Months 18-42
Maintenance of Intervention Reach
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.
Measured: Months 18-42
Maintenance of Blood Pressure Control
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.
Measured: Months 18-42
24-hour Ambulatory Blood Pressure Control among Patients with Lupus Nephritis
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.
Measured: Evaluated at months 0, 6, 9, and then every 3 months through month 18.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study startApr 2027 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erthematosus (SLE)Studies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Joyce Chang, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792733
- Sponsor's protocol ID
- P00054342
- Other IDs
- BPS-2025C1-43826
- Acronym
- ABOUT TIME
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Implementation Strategies to Advance Cardiovascular Health in Children With Lupus
- ClinicalTrials.gov ID
- NCT07792733
- Acronym / sponsor ID
- ABOUT TIME / P00054342
- Conditions
- Systemic Lupus Erthematosus (SLE)
- Keywords
- lupus, SLE
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Apr 2027 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Health Navigator without a Pre-Visit Worksheet | Active comparator | Other: Health Navigator EngagementAdding only the health navigator engagement intervention |
| Team Charter with Performance Monitoring without a Pre-Visit Worksheet | Active comparator | Other: Team Charter with Performance MonitoringAdding only the team charter with performance monitoring intervention. |
| Health Navigator with a Pre-Visit Worksheet | Active comparator | Other: Health Navigator Engagement, Other: Pre-visit worksheetAdding both the health navigator engagement and pre-visit worksheet interventions |
| Team Charter and Performance Monitoring with a Pre-Visit Worksheet | Active comparator | Other: Health Navigator Engagement, Other: Pre-visit worksheetAdding both the team charter and performance monitoring and pre-visit worksheet interventions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (24 listed)
- 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
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Navigator EngagementAdding 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. | Other | Health Navigator with a Pre-Visit Worksheet, Health Navigator without a Pre-Visit Worksheet, Team Charter and Performance Monitoring with a Pre-Visit Worksheet |
| Team Charter with Performance MonitoringCare 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. | Other | Team Charter with Performance Monitoring without a Pre-Visit Worksheet |
| Pre-visit worksheetCare 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. | Other | Health Navigator with a Pre-Visit Worksheet, Team Charter and Performance Monitoring with a Pre-Visit Worksheet |
Primary outcome
Representative Reach of the Implementation Strategies
Time frame: 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.
Fidelity: The extent to which the hypertension evaluation and management interventions are delivered as intended.
Time frame: 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.
Improvement in Blood Pressure Control
Time frame: 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.
5 secondary outcomes
Fidelity to Dietary Sodium Counseling
Time frame: Evaluated at months 0, 18, and 30.
Maintenance of Intervention Fidelity
Time frame: Months 18-42
Maintenance of Intervention Reach
Time frame: Months 18-42
Maintenance of Blood Pressure Control
Time frame: Months 18-42
24-hour Ambulatory Blood Pressure Control among Patients with Lupus Nephritis
Time frame: Evaluated at months 0, 6, 9, and then every 3 months through month 18.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Health Navigator Engagement, Team Charter with Performance Monitoring and Pre-visit worksheet in people with Systemic Lupus Erthematosus (SLE), run by Boston Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Representative Reach of the Implementation Strategies (time frame: Evaluated at months 0, 6, 9, and then every 3 months through month 18.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.