NCT05693571

Engagement in CHildhood-Onset Systemic Lupus

Engagement and Depression in Adolescents and Young Adults With CHildhood-Onset Systemic Lupus

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 15 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This registration is exclusive to the pilot study (Protocol Aim 2). The primary objective of Aim 2 is to assess the feasibility and acceptability of an adapted Valera application (app) in adolescents and young adults (AYA) with childhood-onset systemic lupus erythematosus (cSLE). As a part of Aim 1 (not a component of this registration), using a recognized patient-engaged methodology, "ADAPT-ITT"22, the study team will iteratively adapt and test the content and utilities of the app for cSLE AYA. During the 6-month pilot study which constitutes Aim 2, the investigator team will examine feasibility and acceptability through mixed-methods. Feasibility and acceptability will be assessed via app use and validated feasibility and acceptability of intervention measures.

Conditions

• Lupus Erythematosus, Systemic
• Depression

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-05
• Primary completion: 2026-12-01
• Completion: 2027-02-01
• First posted: 2023-01-23
• Last updated: 2025-09-30

Locations

1 site across 1 country: United States