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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

ECHOS Trial Summary

This trial is looking into if depression symptoms affect how well young people with lupus follow medical care, and whether a mobile app could help.

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.Check my eligibility
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.See study design
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.

ECHOS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility - application utilization (percentage of participants who utilize the Valera application)
Feasibility of the Intervention Measure (Participant Rating of Application Feasibility)
Secondary outcome measures
Acceptability of the Intervention Measure (Participant Rating of Application Acceptability)
Other outcome measures
Depression symptom severity
Engagement in Care - Number of participants with one or more lupus visits
SLE disease activity - clinically assessed
+1 more

ECHOS 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
444 Previous Clinical Trials
582,520 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
485 Previous Clinical Trials
1,086,860 Total Patients Enrolled

Media Library

Valera Pilot Study Clinical Trial Eligibility Overview. Trial Name: NCT05693571 — N/A
Systemic Lupus Erythematosus Research Study Groups: Valera Pilot Study
Systemic Lupus Erythematosus 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the research team allow participants aged 18 and above to join?

"This clinical trial stipulates that prospective participants should be between 15 and 24 years of age to qualify for enrollment."

Answered by AI

How many participants are involved in this research project?

"Affirmative. The study is currently recruiting participants, as evidenced on clinicaltrials.gov where the trial was first published on September 1st 2023 and revised most recently on August 3rd 2023. It requires 40 enrollees over a single site."

Answered by AI

Am I eligible to join this research endeavor?

"In order for a patient to be accepted into this trial, they must have systemic lupus erythematosus and fall within the 15-24 age bracket. Up to 40 volunteers are requested by this clinical study."

Answered by AI

Is there still availability for participants in this experiment?

"As evidenced on clinicaltrials.gov, this medical research is presently recruiting volunteers to take part in the study. The initial posting was made on September 1st 2023 with an update published later that month on August 3rd."

Answered by AI
~27 spots leftby Nov 2026