SMYLS: A Self-management Program for Youth Living With Sickle Cell Disease
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
- Consistency of Intervention Delivery
研究概览
简要总结
The purpose of this study is to find out whether a web-based intervention using a mobile device is helpful for teens learning to care for and manage symptoms of sickle cell disease. The intervention lasts 12 weeks with a 3-month follow up period, and uses a smartphone or a tablet.
详细描述
The purpose of the proposed study is to test the feasibility of SMYLS, an mHealth intervention designed to facilitate self-management behaviors in children and adolescents with sickle cell disease (SCD). Specifically, the investigators propose to test the feasibility of the intervention for improving transition from parent-managed to adolescent self-managed care. In addition, the investigators will evaluate the communication that takes place via the intervention between adolescents, their parents/caregivers, and healthcare providers. The investigators will work with the MUSC Pediatric Sickle Cell Clinic to identify and recruit 5 healthcare providers of children with SCD and 30 dyads of adolescents ages 11 - 17 SCD and their parent/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
- 11 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of SCD as reported by provider
- •self-reported history of pain at least once per month
- •caregiver/parent willingness to participate
- •owns a smartphone
排除标准
- •not under the care of a provider participant
- •cognitive disability or delay that precludes ability to participate, defined as classified severe neurocognitive deficits as documented by neuropsychological evaluation in the medical record
- •lack of wi-fi access
结局指标
主要结局
Consistency of Intervention Delivery
时间窗: 24 weeks
Number of participants (adolescent/caregiver dyads and young adults) to whom instructions on the intervention were provided as recorded in study logs
Rate of Recruitment: Dyads
时间窗: 6 months
Number of participant dyads recruited and enrolled per week. (Benchmark is 2 dyads recruited and enrolled per week to reach sample size of 30 dyads)
Participant Adherence to the Intervention
时间窗: baseline to 6 weeks
Number of participants (adolescent/caregiver dyads and young adults) using the app from baseline to 6 weeks
Projection of Future Adoption
时间窗: 12 weeks
Number of participants (adolescent/caregiver dyads and individual young adults) who report they are likely or very likely to continue using the intervention during post-intervention, semi-structured interviews
Participant (Adolescent/Caregiver Dyads and Young Adults) Adherence to the Intervention From 6 Weeks to 12 Weeks
时间窗: 6 weeks to 12 weeks
Number of participants (adolescent/caregiver dyads and young adults) who used the intervention from week 6 to week 12
Participant (Adolescent/Caregiver Dyads and Young Adults) Adherence to the Intervention From 12 Weeks to 24 Weeks
时间窗: 12 weeks to 24 weeks
Number of participants (adolescent/caregiver dyads and young adults) who used the intervention from week 12 to week 24
Rate of Recruitment: Young Adults
时间窗: 6 months
Number of young adult participants recruited and enrolled per week. (Benchmark is 2 young adults recruited per week to reach a sample size of 15).
次要结局
- Difference in Mean Scores for Anxiety From Baseline to End-of-Intervention(baseline, 12 weeks)
- Difference in Mean Scores for Fatigue From Baseline to End-of-Intervention(baseline, 12 weeks)
- Difference in Mean Scores for Self-Efficacy 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)
- Differences in Mean Scores for Pain Intensity From Baseline to End-of-interention(baseline, 12 weeks)
- Difference in Mean Pain Score Rating From Baseline to End-of-Intervention(baseline, 12 weeks)
- Difference in Mean Scores for Transition Readiness From Baseline to End-of-intervention(baseline, 12 weeks)
- Differences in Mean Scores for Condition-Specific Quality of Life From Baseline to End-of-Intervention(baseline, 12 weeks)
- Differences in Mean Scores for Quality of Life From Baseline to End-of-Intervention(baseline, 12 weeks)
研究者
Shannon Phillips
Associate Professor
Medical University of South Carolina