Promoting Health-Related Quality of Life in Pediatric Lupus Patients: Development and Implementation of a Tailored Brain Health Intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Number of participants recruited
研究概览
简要总结
This project will work closely with patients to design and test a new program that supports brain health in children and youth with childhood-onset lupus (cSLE). The investigators will see how practical and helpful the program is for patients.
详细描述
The proposed project will use a patient-informed participatory action approach to develop and assess preliminary feasibility and acceptability of an intervention tailored to address the specific brain health needs of cSLE patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receive subject-informed consent;
- •Have a current diagnosis of cSLE that meets the 1997 American College of Rheumatology (ACR) or System Lupus International Collaborating Clinics (SLICC) classification criteria
- •Aged 13-18 years old
排除标准
- •Conditions that significantly affect cognition (e.g., intellectual disability diagnosis, active psychosis), hearing loss or vision problems precluding participation in group
- •Non-English speaking
- •Lack of access to technology that would allow them to participate in the virtual intervention (e.g., phone, tablet, computer, etc.)
结局指标
主要结局
Number of participants recruited
时间窗: 1 year
Feasibility will be assessed by rates of participant recruitment.
Number of intervention sessions attended
时间窗: through study completion, an average of 1 year
Feasibility will be assessed by rates of participant session attendance.
Number of participants completing the intervention
时间窗: through study completion, an average of 1 year
Feasibility will be assessed by rates of participant intervention completion.
Acceptability ratings
时间窗: 0-2 weeks post-intervention
Participant acceptability will be determined ratings of their satisfaction with aspects of the program on a brief survey using 5-point Likert scales (ranging from "dissatisfied" to "extremely satisfied").
Qualitative feedback on feasibility and acceptability of the intervention
时间窗: 0-2 weeks post-intervention
Semi- structured interviews administered to participants post-intervention will also assess intervention feasibility and acceptability.
次要结局
- Depressive symptoms(Baseline and 10 weeks)
- Anxiety symptoms(Baseline and 10 weeks)
- Executive function(Baseline and 10 weeks)
- Self-efficacy(Baseline and 10 weeks)
- Social engagement(Baseline and 10 weeks)
- Medication adherence(Baseline and 10 weeks)
- Health-related quality of life(Baseline and 10 weeks)
研究者
Andrea Knight
Clinical Investigator
The Hospital for Sick Children