Engagement in CHildhood-Onset Systemic Lupus

Part of paid clinical trials in The Bronx, New York.

Sponsor
Montefiore Medical Center
Study ID
NCT05693571
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
15 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Valera Smart Phone Application and Care Manager Dashboard — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Dec 5, 2024
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Valera Pilot Study
    All participants in the open-label pilot study will be provided with the Valera smart phone application and online care manager dashboard

Primary Outcome Measure

Feasibility - Application Utilization [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Medical CenterThe BronxNew York10467-

Find similar trials in The Bronx, NY

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Montefiore Medical Center· The Bronx, NY

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