Team-based Implementation of Hypertension Management in Childhood Lupus (ABOUT TIME)
25. august 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
1200
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
|
Aktiv komparator: 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.
|
|
Aktiv komparator: 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.
|
|
Aktiv komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Representative Reach of the Implementation Strategies
Tidsramme: 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.
|
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.
Tidsramme: 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.
|
|
Improvement in Blood Pressure Control
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Fidelity to Dietary Sodium Counseling
Tidsramme: 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.
|
|
Maintenance of Intervention Fidelity
Tidsramme: 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
Tidsramme: 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
|
|
Maintenance of Blood Pressure Control
Tidsramme: 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
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. april 2027
Primær fullføring (Antatt)
30. november 2028
Studiet fullført (Antatt)
30. november 2030
Datoer for studieregistrering
Først innsendt
21. august 2026
Først innsendt som oppfylte QC-kriteriene
25. august 2026
Først lagt ut (Faktiske)
28. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- P00054342
- BPS-2025C1-43826 (Annet stipend/finansieringsnummer: Patient-Centered Outcomes Research Institute)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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