Clinical trial NCT05693571: Engagement in CHildhood-Onset Systemic Lupus
Official title: Engagement and Depression in Adolescents and Young Adults With CHildhood-Onset Systemic Lupus
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Lupus Erythematosus, Systemic
Depression
Keywords: Engagement in care
Mobile health
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Childhood Arthritis and Rheumatology Research Alliance
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2023-01-23
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

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.

Detailed description: This registration is exclusive to the pilot study (Protocol Aim 2). The primary objective of Aim 2 is to assess the feasibility and acceptability of an adapted Valera application (app) in adolescents and young adults (AYA) with childhood-onset systemic lupus erythematosus (cSLE). As a part of Aim 1 (not a component of this registration), using a recognized patient-engaged methodology, "ADAPT-ITT"22, the study team will iteratively adapt and test the content and utilities of the app for cSLE AYA. During the 6-month pilot study which constitutes Aim 2, the investigator team will examine feasibility and acceptability through mixed-methods. Feasibility and acceptability will be assessed via app use and validated feasibility and acceptability of intervention measures.

Eligibility criteria: 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).

Primary outcomes:
measure: Feasibility - Application Utilization
timeFrame: 6 months
measure: Feasibility of the Intervention Measure (Participant Rating of Application Feasibility)
timeFrame: 6 months
Secondary outcomes:
measure: Acceptability of the Intervention Measure (Participant Rating of Application Acceptability)
timeFrame: 6 months
Other outcomes:
measure: Engagement in Care - Number of participants with one or more lupus visits
timeFrame: 6 months
measure: Change in SLE disease activity - patient reported
timeFrame: 3 months
measure: Change in SLE disease activity - patient reported
timeFrame: 6 months
measure: Change in SLE disease activity - clinically assessed
timeFrame: 3 months
measure: Change in SLE disease activity - clinically assessed
timeFrame: 6 months
measure: Change in Depression symptom severity - Beck Depression Inventory-II (BDI-II)
timeFrame: 3 months
measure: Change in Depression symptom severity - Beck Depression Inventory-II (BDI-II)
timeFrame: 6 months
measure: Change in Depression symptom severity - Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 3 months
measure: Change in Depression symptom severity - Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 6 months
measure: Change in Perceived Stress
timeFrame: 3 months
measure: Change in Perceived Stress
timeFrame: 6 months
measure: Change in Self efficacy for medications and therapy
timeFrame: 6 months
measure: Change in Stigma
timeFrame: 6 months
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Tamar Rubinstein, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: