Self-Management for Youth and Families Living With Sickle Cell Disease - SMYLS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Rates of Recruitment
研究概览
简要总结
The purpose of this proposal is to integrate family-centered self-management strategies with mobile health (mHealth) technology to improve reach, self-management behaviors, and child and caregiver physical and psychosocial symptoms and quality of life. Specifically, the investigators propose to conduct feasibility testing of SMYLS, which has been adapted based on user feedback in the first phase of this study. First the investigators will work with the Medical University of South Carolina (MUSC) Pediatric Sickle Cell Clinic to identify and recruit families with children with sickle cell disease (SCD) in the community, statewide. Next, the investigators will test the feasibility of the intervention with 30 dyads of children ages 8 - 17 with sickle cell disease and their parent or primary caregiver, (N=60)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children ages 8 - 17 years and parent or primary caregiver 18 years or older
- •child with sickle cell disease, as reported by clinician at MUSC Pediatric Sickle Cell Clinic
排除标准
- •Parent/caregiver or child with cognitive disability or delay that precludes ability to participate
- •Lack of wi-fi access
结局指标
主要结局
Rates of Recruitment
时间窗: Assessed each week over a period of 6 months, cumulative data up to 6 months is reported.
Number of weeks required to recruit 30 participants.
Acceptability of Intervention
时间窗: Assessed each week over a period of 6 months, cumulative data up to 6 months is reported.
Number of participants reporting problems with the intervention (mHealth app) per week.
Participant Adherence to Intervention
时间窗: baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months
Number of participants who used the intervention (mHealth application) from baseline to mid-intervention, from mid-intervention to end-of-intervention, and from end-of-intervention to follow-up, assessed by number of participants who logged into and used the app, stored in the app's back end database.
次要结局
- Difference in Mean Scores for Anxiety From Baseline to End-of-intervention(baseline, 12 weeks)
- Difference in Mean Pain Score Rating From Baseline to End-of-intervention(baseline, 12 weeks)
- Difference in Mean Caregiver Self-efficacy Score From Baseline to End-of-intervention(baseline, 12 weeks)
- Differences in Mean Scores on Depressive Symptoms From Baseline to End-of-intervention(baseline,12 weeks)
- Difference in Mean Scores for Fatigue From Baseline to End-of-intervention(baseline, 12 weeks)
- Differences in Mean Scores for Pain Intensity From Baseline to End-of-intervention(baseline, 12 weeks)
- Home Medication Administration(12 weeks)
- Differences in Mean Scores for Quality of Life From Baseline to End-of-intervention(baseline, 12 weeks)
- Differences in Mean Scores for Disease-related Quality of Life From Baseline to End-of-intervention(baseline, 12 weeks)
- Clinic Appointment Attendance(12 weeks)