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

Status: Enrolling_by_invitation
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Maximum Age: 25
Healthy Volunteers: f
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• 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)

Locations
United States
New York
Montefiore Medical Center
The Bronx
Time Frame
Start Date: 2024-12-05
Completion Date: 2027-02
Participants
Target number of participants: 40
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Montefiore Medical Center
Collaborators: Childhood Arthritis and Rheumatology Research Alliance, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

This content was sourced from clinicaltrials.gov

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