SCThrive: Improving Self-Management in Adolescents With Sickle Cell Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Scores on Behavioral Activation Measure at Baseline and 6 Weeks (Post-treatment)
研究概览
简要总结
The objective of this study is to determine the feasibility and acceptability of SCThrive, a an innovative, technology-enhanced, group self-management intervention that uses a mixed in-person and online format and supported by a tailored mHealth tool, iManage. The study will also evaluate the initial efficacy of SCThrive for increasing behavioral activation (BA) in adolescents with Sickle Cell Disease (SCD) ages 13 to 21. The investigators hypothesize that participants in the SCThrive group will show greater BA (primary outcome) at post-treatment than the attention control group, and that participants in the SCThrive group will continue to show significantly greater BA at the six week follow-up compared to the attention control group. Investigators will also explore whether SCThrive is associated with greater improvements in self-management behaviors and quality of life (secondary outcome) compared to attention control at the six-week follow-up assessment.
详细描述
The objective of this study is to determine the feasibility and acceptability of SCThrive, a an innovative, technology-enhanced, group self-management intervention that uses a mixed in-person and online format and supported by a tailored mHealth tool, iManage. The study will also evaluate the initial efficacy of SCThrive for increasing behavioral activation (BA) in adolescents with Sickle Cell Disease (SCD) ages 13 to 21.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient of CCHMC Sickle Cell Clinic.
- •Confirmed diagnosis of SCD with SS, SB0Thal or SC genotype.
- •13-21 years of age.
- •On or eligible for disease-modifying therapies.
- •Caregiver (or AYA > 18 years) consent that the participant will be the sole user of the tablet, report immediately if it is damaged or lost, return it at the end of the study, and log on to sessions from a private location.
排除标准
- •another chronic disease (which would complicate measurement of behavioral activation)
- •Non-English-speaking (<5% of the target population); or
- •cognitive or psychiatric disorder that the physician or study therapists believe would impair study participation. Patients who desire participation but are not eligible will be referred to the SCD Clinic social worker for assistance with self-management as this is the usual procedure.
研究组 & 干预措施
Attention Control
6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm.
SCThrive
SCThrive Intervention for Adolescents with SCD - 6 week self-management group
干预措施: SCThrive Intervention for Adolescents with SCD (Behavioral)
结局指标
主要结局
Scores on Behavioral Activation Measure at Baseline and 6 Weeks (Post-treatment)
时间窗: baseline, 6 weeks (post-treatment)
Participants complete the Patient Activation Measure (PAM-13), which is a 13 item measure on skills, knowledge, confidence and readiness for self-management developed by Hibbard et al., 2005. Items are rated on a 4-point Likert scale of 1 = "Disagree Strongly" to 3 = "Strongly Agree." Raw scores range from 13 to 52 and are converted to scores that range from 0 to 100. This score was then divided into four levels of activation, which reflect a developmental progression from being passive with regard to one's health to being proactive: Level 1 (score of 0.0 - 47.0), Level 2 (47.1 - 55.1), Level 3 (55.2 - 72.4), and Level 4 (72.5 - 100). Higher scores indicate more behavioral activation.
次要结局
- Total Scores on the UNC TRxANSITION Scale at Baseline and 6 Weeks Post-Treatment(baseline, 6 weeks (post-treatment))
- Scores on a Self-management Measure at Baseline and 6 Weeks (Post-treatment)(baseline, 6 weeks (post-treatment))