Mobile App Intervention for Childhood-Onset Lupus

(ECHOS Trial)

Enrolling by invitation at 1 trial location

Overseen By Sheza Suleman

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Disqualifiers: Non-Spanish/English, Transitioning care, Psychotic disorders

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how depression, particularly anhedonia, might impact young people's adherence to medical care for lupus. It also tests whether the Valera Smart Phone Application, a specially designed mobile app, can improve both depression symptoms and care engagement. The trial seeks participants aged 15-24 from the Bronx, New York, who were diagnosed with lupus before age 19 and are currently followed at the Children's Hospital at Montefiore. Participants will use the app for six months and provide feedback on its effectiveness and usability. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative research that could enhance care for young people with lupus.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a mobile app to help with lupus care and depression, so it's likely you can continue your current treatment, but please confirm with the study team.

What prior data suggests that this mobile health application is safe for adolescents and young adults with lupus?

Research has shown that mobile health apps like the Valera Smart Phone Application are generally safe. These apps help manage health conditions by providing educational materials and support. No evidence suggests serious safety concerns or harmful effects from using health apps like Valera.

This trial, in its early stages, aims to assess the app's usability and user interaction. The app does not involve medication or medical procedures, making it low-risk. Participants will use the app to manage their lupus care and mood symptoms. The main goal is to improve how young people with lupus manage their health and feel about their well-being.

In summary, using the Valera app is considered safe, with no reported harmful effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Valera Smart Phone Application is unique because it uses digital technology to help manage childhood-onset lupus, a condition where the immune system attacks healthy tissues. Unlike traditional treatments that mainly rely on medications like corticosteroids and immunosuppressants, Valera offers a mobile app that provides personalized support and real-time communication with care managers. Researchers are excited about this innovative approach because it empowers patients and families with tools to manage symptoms more effectively, potentially improving quality of life and adherence to treatment plans.

What evidence suggests that this mobile app is effective for improving care engagement and depression symptoms in adolescents and young adults with lupus?

Research has shown that mobile apps like the Valera Smart Phone Application, which participants in this trial will use, can help young people with lupus stay engaged in their healthcare. This app provides tools and information about mental health and lupus, aiming to assist users in taking their medication as prescribed and managing their health more effectively. Early findings suggest that when young people help design these apps, they are more likely to use them effectively. Some studies have found that using mobile health apps can lead to better medication habits and more regular follow-up care. Although specific data on the Valera app is limited, personalized health apps appear promising for supporting young patients with lupus. ^{2 4 6 7 8}

Who Is on the Research Team?

Tamar B Rubinstein, MD, MS

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am 15-24 years old with diagnosed lupus and treated at the Children's Hospital at Montefiore.

I was diagnosed with lupus before I turned 19.

Exclusion Criteria

Participants anticipating transitioning to an outside rheumatologist for lupus care within the period of study follow-up

I do not speak Spanish or English.

I do not have a current psychotic disorder but may have ADHD, anxiety, OCD, PTSD, an eating disorder, or a history of substance abuse or depression.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Study

Participants use the Valera mobile health application to improve engagement in care and depression symptoms

6 months

Participants complete questionnaires and may participate in focus groups

Follow-up

Participants are monitored for changes in self-efficacy, stigma, SLE disease activity, depression symptom severity, and perceived stress

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Valera Smart Phone Application

Trial Overview 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.

How Is the Trial Designed?

Group I: Valera Pilot Study Experimental Treatment 1 Intervention

All participants in the open-label pilot study will be provided with the Valera smart phone application and online care manager dashboard

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Childhood Arthritis and Rheumatology Research Alliance

Collaborator

Trials

5

Recruited

20,500+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Published Research Related to This Trial

In a study of 106 women with systemic lupus erythematosus (SLE), 60% reported high medication adherence, but younger patients and those with shorter disease duration were less likely to adhere to their medication regimens.

Lower self-efficacy, worsening cognitive function, and increased depression were significantly associated with lower medication adherence, suggesting that these factors should be routinely assessed to identify patients who may need targeted support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Psychosocial and Neuropsychiatric Factors on Medication Adherence in a Cohort of Women With Systemic Lupus Erythematosus. Flower, C., Hambleton, I., Campbell, M.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05693571

Engagement in CHildhood-Onset Systemic Lupus Valera mobile health application will provide educational materials around mental health and Systemic Lupus Erythematosus (SLE) and the ability to connect to a ...

2. jrheum.org jrheum.org/content/52/Suppl_1/62.1

PARTNERING WITH ADOLESCENTS AND YOUNG ... This project aimed to adapt an existing mHealth app for AYA with lupus to improve engagement in care with input from youth through a structured participatory ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11293375/

patient and caregiver recommendations for a mobile health ... The project proposes to use mobile health or application (app)-based technology to study medication adherence in paediatric systemic lupus ...

4. lupus.bmj.com lupus.bmj.com/content/8/1/e000494

Delivering clinical trials at home: protocol, design and ... The primary outcome (medication adherence) is evaluated using electronic medication event-monitoring, plasma drug levels, patient questionnaires ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10582195/

Improving outcomes of pediatric lupus care delivery with ... We evaluated high-quality care delivery in the context of provider goal-setting activities and a multidisciplinary care model.

6. trials.arthritis.org trials.arthritis.org/trials/NCT05693571

Engagement in CHildhood-Onset Systemic Lupus ... Valera smart phone application and online care manager dashboard ... Valera mobile health application will provide educational materials around mental health and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8270778/

An Update on the Management of Childhood-Onset Systemic ... Management practices for cSLE patients include evaluations of disease activity and cumulative damage scores, routine non-live vaccinations, physical activity,

8. jrheum.org jrheum.org/content/52/Suppl_1/60.full.pdf

60.full.pdf ADULTS WITH CHILDHOOD-ONSET LUPUS TO IMPROVE. ENGAGEMENT IN CARE ... CHILDHOOD-ONSET SLE WITH DATA-DRIVEN METHODS. Nicholas Chan1 ...