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Engagement in CHildhood-Onset Systemic Lupus

NCT05693571 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-09-30

No results posted yet for this study

Summary

The goal of this observational (Aim 1) and pilot study (Aim 2) is to better understand how depression symptoms may contribute to how well adolescent and young adults with lupus follow-up with their lupus clinical care. The main questions the overall study attempts to answer are:

1. Whether anhedonia (a core symptom of depression) predicts disengagement in care
2. Whether a patient-tailored mobile health application built to improve both engagement in care and depression symptoms will be feasible and acceptable to adolescents and young adults with lupus.

Participants with systemic lupus, ages 15-24 from the Bronx, New York will be asked to complete questionnaires; some will be asked to participate in focus groups to help adapt the mobile health app; participants will also be invited to join a pilot study to try the mobile health app for 6 months and answer questionnaires to document the experience.

Conditions

Interventions

BEHAVIORAL

Valera Smart Phone Application and Care Manager Dashboard

Valera mobile health application will provide educational materials around mental health and Systemic Lupus Erythematosus (SLE) and the ability to connect to a SLE care team via a care manager.

Sponsors & Collaborators

  • Childhood Arthritis and Rheumatology Research Alliance

    collaborator OTHER

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Tamar Rubinstein, MD, MS · Montefiore Medical Center

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-05
Primary Completion
2026-12-31
Completion
2027-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05693571 on ClinicalTrials.gov