Engagement and Depression in Adolescents and Young Adults With CHildhood-Onset Systemic Lupus
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Feasibility - Application Utilization
研究概览
简要总结
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:
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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).
研究组 & 干预措施
Valera Pilot Study
All participants in the open-label pilot study will be provided with the Valera smart phone application and online care manager dashboard
干预措施: Valera Smart Phone Application and Care Manager Dashboard (Behavioral)
结局指标
主要结局
Feasibility - Application Utilization
时间窗: 6 months
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.
Feasibility of the Intervention Measure (Participant Rating of Application Feasibility)
时间窗: 6 months
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.
次要结局
- Acceptability of the Intervention Measure (Participant Rating of Application Acceptability)(6 months)