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Mobile App Intervention for Childhood-Onset Lupus (ECHOS Trial)

N/A
Recruiting
Led By Tamar Rubinstein, MD, MS
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if a custom mobile app can help young people with lupus stay engaged in their medical care and manage depression. The study focuses on adolescents and young adults from the Bronx, ages 15-24. The app offers personalized support to help them keep up with health appointments and improve their mood.

Who is the study for?
This trial is for young individuals aged 15-24 in the Bronx, NY with childhood-onset systemic lupus erythematosus (cSLE). They must meet specific lupus criteria and have been diagnosed before age 19. It's not for those who don't speak English or Spanish, plan to change rheumatologists soon, or have current psychotic disorders.
What is being tested?
The study is testing a mobile health app designed to help adolescents and young adults with lupus manage depression symptoms and improve engagement in their healthcare. Participants will use the app for six months while completing questionnaires about their experience.
What are the potential side effects?
Since this trial involves using a smartphone application rather than medication, traditional side effects are not expected. However, there may be emotional or psychological impacts from engaging with content related to depression and personal health management.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility - Application Utilization
Feasibility of the Intervention Measure (Participant Rating of Application Feasibility)
Secondary study objectives
Acceptability of the Intervention Measure (Participant Rating of Application Acceptability)
Other study objectives
Change in Depression symptom severity - Beck Depression Inventory-II (BDI-II)
Change in Depression symptom severity - Patient Health Questionnaire-9 (PHQ-9)
Change in Perceived Stress
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Valera Pilot StudyExperimental Treatment1 Intervention
All participants in the open-label pilot study will be provided with the Valera smart phone application and online care manager dashboard

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
458 Previous Clinical Trials
588,821 Total Patients Enrolled
Childhood Arthritis and Rheumatology Research AllianceOTHER
3 Previous Clinical Trials
20,413 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
502 Previous Clinical Trials
1,089,978 Total Patients Enrolled
2 Trials studying Lupus
270 Patients Enrolled for Lupus
Tamar Rubinstein, MD, MSPrincipal InvestigatorMontefiore Medical Center

Media Library

Valera Pilot Study Clinical Trial Eligibility Overview. Trial Name: NCT05693571 — N/A
Lupus Research Study Groups: Valera Pilot Study
Lupus Clinical Trial 2023: Valera Pilot Study Highlights & Side Effects. Trial Name: NCT05693571 — N/A
Valera Pilot Study 2023 Treatment Timeline for Medical Study. Trial Name: NCT05693571 — N/A
~27 spots leftby Dec 2026
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