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Engagement in CHildhood-Onset Systemic Lupus
The goal of this observational and pilot study 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 it aims 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; patients 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:
🦠 Lupus Erythematosus, Systemic 🦠 Depression
🗓️ Study Start (Actual) August 2024
🗓️ Primary Completion (Estimated) November 2026
✅ Study Completion (Estimated) November 2026
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Bronx, New York, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Participants 15-24 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 Criteria:

    • * 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).
Ages Eligible for Study: 15 Years to 24 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 5 December 2022
  • First Submitted that Met QC Criteria 11 January 2023
  • First Posted 23 January 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 July 2024
  • Last Update Posted 11 July 2024
  • Last Verified July 2024
I'm interested ...!!