A Socio-ecological Approach for Improving Self-management in Adolescents With SCD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 310
- 试验地点
- 8
- 主要终点
- Patient Activation
研究概览
简要总结
The goal of this clinical trial is to evaluate the impact of SCThrive (a behavioral self-management intervention) on patient activation, self-management behaviors, daily functioning, and emergency room visits in 260 adolescents and young adults with sickle cell disease (SCD) ages 13-21 receiving care at 1 of 4 pediatric SCD clinics.
The main question[s]it aims to answer are:
- Does SCThrive improve patient activation?
- Does SCThrive improve self-management behaviors, daily functioning, and decrease emergency room visits?
- Are any improvements maintained 3 months after treatment?
Participants will complete self-management related surveys before, after, and 3 months following their participation in an 8- week, virtual group intervention with an accompanying mobile app (SCThrive).
Researchers will compare outcomes for participants who receive SCThrive and participants who receive uniform standard care (SCHealthED which = standard of care plus SCD educational text messages) to see if there are differences in patient activation, self-management behaviors, daily functioning, and emergency room visits.
详细描述
The research team's pilot work demonstrated improved patient activation (knowledge, skills, and self-efficacy) and self-management behaviors in adolescents and young adults (AYA) with sickle cell disease (SCD) compared to a control condition. Further analyses revealed that participants who used the app more frequently showed greater improvements. Thus, this study will maximize the clinical benefit of SCThrive by 1) adding app engagement strategies, 2) conducting a more systematic assessment of barriers including social contributors to health, and 3) integrating ways to address these barriers into the intervention.
Study Aims: The aims are to examine the impact of SCThrive on patient activation (primary outcome; Aim 1) and self-management behaviors, daily functioning, and emergency room visits (secondary outcomes) at post-treatment and follow-up (Aim 2). It is hypothesized that adolescents randomized to SCThrive will have greater improvement in patient activation (primary outcome) compared to those randomized to uniform standard care (control condition). The research team will also explore the relationship between social determinants of health (SDOH)-related barriers (e.g., stigma, access to care) and treatment response (i.e., patient activation and self-management behaviors).
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigator and Outcomes assessors will not know the condition to which participants have been randomized.
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 a participating SCD Clinic
- •Confirmed diagnosis of SCD
- •13-21 years of age
排除标准
- •Another chronic disease (which would complicate measurement of patient activation)
- •Non-English-speaking
- •Cognitive or psychiatric disorder that the physician or study therapists believe would impair study participation.
研究组 & 干预措施
Active Treatment
SCThrive is a virtual, 8-week, virtual group-based, behavioral self-management intervention that includes daily use of a companion mobile app.
干预措施: SCThrive (Behavioral)
Control Condition
Participants randomized to SCHealthED will receive usual care plus 7 text messages consisting of SCD educational facts to ensure the care is uniform across sites.
干预措施: SCHealthED (Other)
结局指标
主要结局
Patient Activation
时间窗: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends
Self-reported patient activation as measured by the Patient Activation Measure -13 (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
- Health-related quality of life(baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends)
- Emergency Room (ER) Visits(6 months prior to treatment; 6 months post-treatment)
- Self-Management Skills(baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends)
- Self-Management Behaviors(baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends)
- Daily Functioning(baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends)