Empowering Adolescents and Young Adults With Sickle Cell Disease as Partners in Treatment Decision Making (EMPOWER-AYA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Participant Recruitment Rate
研究概览
简要总结
This study will evaluate the acceptability, feasibility, and preliminary efficacy of a shared decision making intervention for adolescents and young adults (AYAs) with sickle cell disease (SCD). 60 AYAs with SCD ages 15-25 and their caregivers and 8 SCD providers will participate in the pilot pragmatic trial. AYAs, caregivers, and providers will be recruited from Nemours Children's Hospital, Delaware (NCH-DE), Nemours Children's Hospital in Orlando, FL (NCH-ORL), and Nemours Children's Health at Wolfson Children's Hospital in Jacksonville, FL (NCH-JAX). NCH-DE participants (n=30) will receive the SDM intervention including a virtual reality patient health education component, whereas NCH-ORL and NCH-JAX participants (n=30) will receive the SDM intervention with standard patient education materials (print, video). SCD providers will be trained to use the toolkit components and will introduce decision aids during an outpatient clinic visit for AYAs who are candidates for one or more disease-modifying therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with SCD ages 15-25 years receiving treatment at Nemours and their caregivers will be included. Patients must be deemed candidates for initiation of one or more disease-modifying therapies by their SCD healthcare provider.
- •Nemours SCD healthcare providers will also be included.
- •English language fluency is a requirement for all participants.
排除标准
- •Patients/ caregivers who previously participated in usability testing of the intervention will be excluded.
- •Patients will also be excluded if they have history of seizures, if their medical status or cognitive functioning preclude completion of interviews, or if no legal guardian is available to provide consent (for patients < 18 years).
- •Providers still completing training will be excluded.
研究组 & 干预措施
Shared Decision Making Toolkit without VR
干预措施: SCD Shared Decision-Making Toolkit for AYAs - without VR (Behavioral)
Shared Decision Making Toolkit including VR
干预措施: SCD Shared Decision-Making Toolkit for AYAs - including VR (Behavioral)
结局指标
主要结局
Participant Recruitment Rate
时间窗: Time of enrollment through study completion, approximately 12 months
Rate of participant enrollment and retention in the study
Disease-Modifying Therapy Knowledge Questionnaire
时间窗: Within 2 weeks post-intervention
Questionnaire assessing patient and caregiver knowledge of disease modifying-therapies for sickle cell disease. Survey will be developed by the research team, and additional details will be included here once items and scoring are finalized.
Patient/Caregiver Satisfaction Questionnaire
时间窗: Within 2 weeks post-intervention
Survey assessing patient/caregiver satisfaction with the intervention. Survey will be developed by the research team, and additional details will be included here once items and scoring are finalized.
Acceptability of Intervention Measure (AIM)
时间窗: Within 2 weeks post-intervention
Questionnaire assessing healthcare provider perspectives on acceptability of the intervention. Total score ranges from 4-20, with higher scores indicating greater acceptability.
Feasibility of Intervention Measure (FIM)
时间窗: Within 2 weeks post-intervention
Questionnaire assessing healthcare provider perspectives on the feasibility of the intervention. Total score ranges from 4-20, with higher scores indicating greater feasibility.
Shared Decision Making Questionnaire (SDM-Q-9)
时间窗: Within 2 weeks post-intervention
Questionnaire assessing patient- and caregiver-reported engagement in decision making. Total score ranges from 0 to 100, with higher scores indicating greater engagement in decision making.
次要结局
- Initiation of disease-modifying therapy(Within 6 months post-intervention)
研究者
Aimee Hildenbrand
Research Scientist
Nemours Children's Clinic