Engagement in CHildhood-Onset Systemic Lupus

NCT05693571 | Enrolling By Invitation DMC

• 2 other identifiers: 2022-14314K23AR080803
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 1.Whether anhedonia (a core symptom of depression) predicts disengagement in care
2. 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.

Conditions

Lupus Erythematosus, Systemic; Depression

Keywords

Engagement in care; Mobile health

Outcome Measures

Primary Outcomes (2)

• Feasibility - Application Utilization

  Feasibility of the Valera health application will determined by the percentage of participants who utilize the Valera platform. Participants with repeated (i.e., ≥ 2) log-ins to both the care management and educational platforms will be considered users. A successful target percentage of ≥ 80% of enrolled participants logging into the care plan on the application and utilizing the messenger system at least twice during the 6-month pilot will be considered highly feasible.

  6 months

• Feasibility of the Intervention Measure (Participant Rating of Application Feasibility)

  Feasibility of the Intervention Measure (FIM) will be assessed by participant rating of application feasibility via administration of a 4-item questionnaire at the end of the pilot study. Responses to each of the 4 questions will be evaluated on a 5-point scale as follows: (1 = "Completely disagree", 2 = "Disagree", 3 = "Neither agree nor disagree", 4 = "Agree", 5 = "Completely agree"). A higher aggregate score denotes a more favorable participant rating of feasibility of the application.

  6 months

Secondary Outcomes (1)

• Acceptability of the Intervention Measure (Participant Rating of Application Acceptability)

  6 months

Other Outcomes (13)

• Engagement in Care - Number of participants with one or more lupus visits

  6 months

• Change in SLE disease activity - patient reported

  3 months

• Change in SLE disease activity - patient reported

  6 months

Study Arms (1)

Valera Pilot Study

EXPERIMENTAL

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

Behavioral: Valera Smart Phone Application and Care Manager Dashboard

Interventions

Valera Smart Phone Application and Care Manager Dashboard BEHAVIORAL

Valera mobile health application will provide educational materials around mental health and Systemic Lupus Erythematosus (SLE) and the ability to connect to a SLE care team via a care manager.

Valera Pilot Study

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Non-Spanish or non-English speaking
• Participants anticipating transitioning to an outside rheumatologist for lupus care within the period of study follow-up
• Current psychotic disorders. However, attention-deficit/hyperactivity disorder, anxiety disorders, obsessive-compulsive disorder, posttraumatic stress disorder, eating disorders, and substance abuse disorders are not uncommon among adolescents and young adults (AYA) and will be allowed. Suicidal ideations (SI) and self-injurious acts (cutting) are common in depression and will be allowed (defined as passive SI).

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Childhood Arthritis and Rheumatology Research Alliance: collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Depression

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior

Study Officials

• Tamar Rubinstein, MD, MS

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: January 23, 2023
• Study Start: December 5, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Following the initial upload of raw data as described above, data will be shared in accordance with the standard six-month period for data uploads. All raw data provided will include an NDA Global Unique Identifier and will not include any personally identifiable information. Any analyzed research data expected to be published will be submitted to the NDA no later than the time of publication. Unpublished data will be shared within a year after project completion.
• Access Criteria: For access to record-level IPD a Data Access Request must be submitted. Users with NDA credentials may submit Data Access Requests for 1 Permission Group at a time (Broad Use, Controlled Access, or Open Access) from the NDA Permissions Dashboard. Each request includes an NDA Data Use Certification signed by the lead recipient and an authorized Signing Official from recipient's research institution. Additional research staff from the same institution may be added by completing the Senior/Key Person Profile section. All recipients on a Data Use Certification must be affiliated with the recipient's research institution. NDA users submitting Data Access Requests for Broad Use and Controlled Access Permission Groups must be sponsored by an NIH recognized institution with a Federalwide Assurance (FWA) and have a research-related need to access NDA data. NDA users submitting Data Access Requests for Controlled Access Permission Groups must adhere to consent-based data use limitations.

Locations

US (1)