Spotlight AQ Randomized Controlled Trial of the Spotlight AQ Survey Platform to Evaluate Its' Efficacy and Applicability in a Clinic Setting.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
The goal of this clinical trial is to compare the Spotlight AQ survey platform to the standard of care (SOC) pre-clinic assessment in adolescents & young adults (16-25 years old) with Type 1 Diabetes (T1D).
The main questions it aims to answer are:
- Does using the Spotlight AQ survey in clinic decrease the A1c in the people who use it?
- Do patients and healthcare providers like using the spotlight AQ survey?
Participants will use the Spotlight AQ survey before coming in to two standard of care T1D clinic visits Participants will fill out surveys describing how they feel about using the Spotlight AQ survey. Some participants may be asked to do an interview to talk about how they feel about the Spotlight AQ survey.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •16-25 years old
- •Patients diagnosed with T1D for at least 6 months
- •On any diabetes treatment
- •Using a Continuous Glucose Monitor (CGM)
- •Willing/ able to use Spotlight AQ tool
- •Able to give verbal assent
- •Patients & parents/caregiver speak English/ Spanish fluently
- •Patients in the Children's Mercy Kansas City Hospital or Boston Children's Hospital network
排除标准
- •<16 years old or >25 years old
- •Mental illness that could seriously reduce their ability to participate in the study
- •Lack of capacity
- •In another T1D intervention study
研究组 & 干预措施
Standard of Care
The pre-clinic survey typically given to patients before clinic visits at each institution
Intervention (Spotlight AQ)
Spotlight AQ is an Artificial Intelligence (AI) powered adaptive survey which identifies the main concerns and gaps in patients tailored to their specific needs in preparation for clinic visits
干预措施: Spotlight AQ Survey platform (Other)
结局指标
主要结局
HbA1c
时间窗: 3 months (approximately)
HbA1c levels of pediatric participants as a %
次要结局
- Participant satisfaction(3 months (approximately))
- The effectiveness of the intervention(3 months (approximately))
- HCP satisfaction with the Spotlight survey(3 months (approximately))
- The approval of participants(3 months (approximately))
- T1D outcomes(3 months (approximately))
研究者
Cintya Schweisberger
Principal Investigator
Children's Mercy Hospital Kansas City