[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05693571":3,"trial-entities:NCT05693571":82,"trial-summary:NCT05693571":86},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":46,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":53,"eligibility_criteria":54,"std_ages":63,"locations":66,"central_contacts":75,"overall_officials":76,"references":80,"see_also_links":81},"NCT05693571","2022-14314","Engagement in CHildhood-Onset Systemic Lupus","Engagement and Depression in Adolescents and Young Adults With CHildhood-Onset Systemic Lupus","ACTIVE_NOT_RECRUITING","2027-02","2026-07","2026-07-31","2024-12-05","Montefiore Medical Center","OTHER",true,"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:\n\n1. Whether anhedonia (a core symptom of depression) predicts disengagement in care\n2. 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.\n\nParticipants 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.","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.",[19,20],"Lupus Erythematosus, Systemic","Depression",[22,23],"Engagement in care","Mobile health","INTERVENTIONAL","PREVENTION",[27],"NA",{"count":29,"type":30},48,"ACTUAL",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","Valera Smart Phone Application and Care Manager Dashboard","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.",[37],"Valera Pilot Study",[39,43],{"measure":40,"description":41,"timeFrame":42},"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",{"measure":44,"description":45,"timeFrame":42},"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.",[47],{"measure":48,"description":49,"timeFrame":42},"Acceptability of the Intervention Measure (Participant Rating of Application Acceptability)","Acceptability of the Intervention Measure (AIM) will be assessed by participant rating of application acceptability 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 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. For purposes of this study a group mean score of ≥4 (representing \"Agree\" or \"Completely agree\") across the 4 items in ≥80% or participants will be an indicator of Acceptability.","ALL","15 Years","25 Years",false,{"inclusion":55,"exclusion":58,"raw_text":62},[56,57],"Participants 15-25 years old meeting American College of Rheumatology (ACR) Revised SLE Classification Criteria and\u002For European League Against Rheumatism\u002FACR Classification Criteria and\u002For 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)",[59,60,61],"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\u002Fhyperactivity 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).","Inclusion Criteria:\n\n* Participants 15-25 years old meeting American College of Rheumatology (ACR) Revised SLE Classification Criteria and\u002For European League Against Rheumatism\u002FACR Classification Criteria and\u002For 2012 SLE International Collaborating Clinic Criteria and followed at the Children's Hospital at Montefiore.\n* Must be diagnosed with SLE before 19 years of age (based on Childhood-onset systemic lupus erythematosus (cSLE) definition)\n\nExclusion Criteria:\n\n* Non-Spanish or non-English speaking\n* Participants anticipating transitioning to an outside rheumatologist for lupus care within the period of study follow-up\n* Current psychotic disorders. However, attention-deficit\u002Fhyperactivity 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).",[64,65],"CHILD","ADULT",[67],{"facility":13,"city":68,"state":69,"zip":70,"country":71,"geoPoint":72},"The Bronx","New York","10467","United States",{"lat":73,"lon":74},40.84985,-73.86641,[],[77],{"name":78,"affiliation":13,"role":79},"Tamar Rubinstein, MD, MS","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":83,"biomarkers":85},[20,84],"Systemic Lupus Erythematosus",[],{"nct_id":4,"found":15,"summary":87,"prompt_version":97},{"design":88,"status":89,"heading":90,"summary":91,"follow_up":92,"word_count":93,"commitments":94,"compensation":95,"drugs_mentioned":96},"This is an interventional pilot study, meaning it tests a new treatment or intervention. It plans to enroll 48 participants.","completed","Valera Smart Phone Application for Childhood-Onset Lupus and Depression","This study is testing a smartphone app called Valera for young people (ages 15-25) who have childhood-onset systemic lupus erythematosus (SLE), a chronic autoimmune disease, and depression. The app provides educational materials about mental health and lupus, and connects you to a care team. Researchers want to see if the Valera app is practical and helpful for improving engagement in care and depression symptoms. They are also studying how depression symptoms, specifically anhedonia (loss of interest or pleasure), might affect how well young people with lupus follow their medical care. The study aims to enroll 48 participants and is currently unclear on its recruitment status.","The main study measures are taken at 6 months after starting the intervention.",105,"You would complete questionnaires, and some participants might join focus groups to help improve the mobile app. The study lasts for 6 months.","Not stated in the trial record.",[],"v2"]