Mobile App Intervention for Childhood-Onset Lupus

(ECHOS Trial)

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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the Valera Smart Phone Application treatment for childhood-onset lupus?

Research suggests that mobile health apps can be useful for managing systemic lupus erythematosus (SLE) by improving medication adherence, which is a common issue in young patients with lupus. An intervention using digital reminders and personalized treatment plans showed promise in helping young adults with childhood-onset lupus stick to their medication schedules. ^{1 2 3 4 5}

Is the Valera Smart Phone Application safe for use in humans?

The research does not provide specific safety data for the Valera Smart Phone Application or similar mobile apps for lupus, but it does mention the feasibility and acceptability of digital interventions for improving medication adherence in young adults with childhood-onset lupus. ^{1 3 5 6 7}

How is the mobile app intervention for childhood-onset lupus different from other treatments?

This mobile app intervention is unique because it combines automated digital reminders with a personalized treatment plan to improve medication adherence in young adults with childhood-onset lupus, which is a novel approach compared to traditional treatments that do not typically focus on adherence through digital means. ^{1 3 5 8 9}

Research Team

Tamar B Rubinstein, MD, MS

Principal Investigator

Montefiore Medical Center

Eligibility Criteria

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 was diagnosed with lupus before I turned 19.

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

Exclusion Criteria

I do not speak Spanish or English.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Mobile health apps for systemic lupus erythematosus and lupus nephritis: a critical appraisal. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Performance and psychometric properties of lupus impact tracker in assessing patient-reported outcomes in pediatric lupus: Report from a pilot study. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Low disease activity state in juvenile-onset systemic lupus erythematosus. [2022]

4. England pubmed.ncbi.nlm.nih.gov

LLDAS is an attainable treat-to-target goal in childhood-onset SLE. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of an innovative adherence intervention for young adults with childhood-onset systemic Lupus Erythematosus. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The Effect of Psychosocial and Neuropsychiatric Factors on Medication Adherence in a Cohort of Women With Systemic Lupus Erythematosus. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Treatment patterns in paediatric and adult patients with SLE: a retrospective claims database study in the USA. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Digital Therapeutic Platform for Management of Systemic Lupus Erythematosus. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Mobile health technologies for the management of systemic lupus erythematosus: a systematic review. [2020]