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Valera Smart Phone Application for Childhood-Onset Lupus and Depression

This study is testing a smartphone app called Valera for young people (ages 15-25) who have childhood-onset systemic lupus erythematosus (SLE), a chronic autoimmune disease, and depression. The app provides educational materials about mental health and lupus, and connects you to a care team. Researchers want to see if the Valera app is practical and helpful for improving engagement in care and depression symptoms. They are also studying how depression symptoms, specifically anhedonia (loss of interest or pleasure), might affect how well young people with lupus follow their medical care. The study aims to enroll 48 participants and is currently unclear on its recruitment status.

Study design
This is an interventional pilot study, meaning it tests a new treatment or intervention. It plans to enroll 48 participants.
What's involved
You would complete questionnaires, and some participants might join focus groups to help improve the mobile app. The study lasts for 6 months.
Compensation
Not stated in the trial record.
Follow-up
The main study measures are taken at 6 months after starting the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05693571

Engagement in CHildhood-Onset Systemic Lupus

Active, Not Recruiting
NAAges 15–25InterventionalPrevention
Montefiore Medical Center
~48 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:Valera Smart Phone Application and Care Manager Dashboard

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility - Application Utilization
Measured over 6 months
+1 more outcome measured

Conditions

Lupus Erythematosus, Systemic
Depression

Explore related trials

DepressionSystemic Lupus Erythematosus

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Tamar Rubinstein, MD, MS · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants 15-25 years old meeting American College of Rheumatology (ACR) Revised SLE Classification Criteria and/or European League Against Rheumatism/ACR Classification Criteria and/or 2012 SLE International Collaborating Clinic Criteria and followed at the Children's Hospital at Montefiore.
Must be diagnosed with SLE before 19 years of age (based on Childhood-onset systemic lupus erythematosus (cSLE) definition)

Exclusion

Non-Spanish or non-English speaking
Participants anticipating transitioning to an outside rheumatologist for lupus care within the period of study follow-up
Current psychotic disorders. However, attention-deficit/hyperactivity disorder, anxiety disorders, obsessive-compulsive disorder, posttraumatic stress disorder, eating disorders, and substance abuse disorders are not uncommon among adolescents and young adults (AYA) and will be allowed. Suicidal ideations (SI) and self-injurious acts (cutting) are common in depression and will be allowed (defined as passive SI).

What this trial measures

  • Feasibility - Application Utilization6 months

    Feasibility of the Valera health application will determined by the percentage of participants who utilize the Valera platform. Participants with repeated (i.e., ≥ 2) log-ins to both the care management and educational platforms will be considered users. A successful target percentage of ≥ 80% of enrolled participants logging into the care plan on the application and utilizing the messenger system at least twice during the 6-month pilot will be considered highly feasible.

  • Feasibility of the Intervention Measure (Participant Rating of Application Feasibility)6 months

    Feasibility of the Intervention Measure (FIM) will be assessed by participant rating of application feasibility via administration of a 4-item questionnaire at the end of the pilot study. Responses to each of the 4 questions will be evaluated on a 5-point scale as follows: (1 = "Completely disagree", 2 = "Disagree", 3 = "Neither agree nor disagree", 4 = "Agree", 5 = "Completely agree"). A higher aggregate score denotes a more favorable participant rating of feasibility of the application.