Engagement in CHildhood-Onset Systemic Lupus

Study Overview
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Brief Summary
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The goal of this observational and pilot study 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 it aims to answer are: Whether anhedonia (a core symptom of depression) predicts disengagement in care 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. Participants with systemic lupus, ages 15-24 from the Bronx, New York will be asked to complete questionnaires; some will be asked to participate in focus groups to help adapt the mobile health app; participants will also be invited to join a pilot study to try the mobile health app for 6 months and answer questionnaires to document the experience.

Official Title
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Engagement and Depression in Adolescents and Young Adults With CHildhood-Onset Systemic Lupus

Conditions
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Lupus Erythematosus, Systemic, Depression

Intervention / Treatment
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* Behavioral: Valera Smart Phone Application and Care Manager Dashboard


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants 15-24 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) Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Valera Pilot Study<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants who utilize the Valera Application (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 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 Response (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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of the Intervention Measure (Participant Rating of Application Acceptability) | Acceptability of the Intervention Measure (AIM) will be assessed by 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 Response (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 the application. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Engagement in care, Mobile health