Multi-component Remote Assessment in Adult Survivors Using a Connected Technology Platform for Healthcare Delivery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Participation rate
研究概览
简要总结
This feasibility study evaluates a 12-week, multi-component remote assessment program for adult survivors of childhood cancer. The study aims to determine the participation and adherence rates to remote monitoring of cardiometabolic health using wearable devices, surveys, and laboratory testing facilitated by a third-party vendor.
Primary Objective - To establish the feasibility of a multi-component remote assessment program for adult survivors.
- The primary outcome for feasibility will be the participation rate (# eligible survivors approached who enroll) and completion rate (# of eligible survivors who enroll and remain on study through completion).
- An additional outcome for feasibility will be adherence to the multicomponent remote assessment among participants.
Secondary Objective
- To estimate the proportion of participants who complete each individual study component (adherence to each individual component monitoring).
详细描述
Survivors of childhood cancer face increased risks of late effects, including cardiometabolic conditions. Due to geographic diversity and mobility limitations, remote research participation is essential. This study pilots a remote assessment platform to monitor cardiometabolic health indicators such as blood pressure, heart rate variability, glucose control, physical activity, sleep, diet, and laboratory biomarkers. Participants will be on-boarded by a vendor, receive devices, and complete assessments remotely. A subset will participate in interviews to evaluate platform acceptability and barriers. The study will assess feasibility through participation and adherence rates, aiming to inform future remote intervention trials.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is ≥18 years of age
- •Participant is enrolled in the St. Jude Life (SJLIFE) cohort
- •Participant is able and willing to provide informed consent
- •Participant has signed a separate consent for the St. Jude banking protocol (TBANK)
- •Participant received anthracycline (≥100 mg/m²), chest or abdominal radiation as part of childhood cancer treatment
- •Participant owns a SmartPhone compatible with the vendor platform, Apple HealthKit, and Dexcom (a wearable device that continuously tracks glucose levels)
- •Participant verbalizes understanding directions for completing remote study activities with the third-party partner
- •Participant is fluent in English
排除标准
- •Participant uses a continuous glucose monitor for diabetes management or has diabetes requiring insulin or more than 1 agent for treatment at baseline
- •Participant is currently enrolled on an intervention or active longitudinal monitoring ancillary study
研究组 & 干预措施
Remote Monitoring Group
Participants will undergo a 12-week remote monitoring program using wearable devices and complete surveys and a one-time lab draw. A subset will participate in interviews post-intervention.
干预措施: Remote Monitoring Program (Behavioral)
结局指标
主要结局
Participation rate
时间窗: Assessed at contact for enrollment of each participant (baseline/screening).
The proportion of eligible survivors approached who enroll in the intervention
On-boarding rate
时间窗: Baseline at study entry through week 12
The proportion of consented participants who successful onboard with the vendor and contribute any study data beyond baseline
Completion rate
时间窗: Baseline at study entry through week 12
The proportion of enrolled survivors who remain on study and complete both baseline and week 12/end of study assessments.
Adherence to the remote monitoring intervention
时间窗: Baseline at study entry through week 12
The proportion of enrolled survivors who complete at least 2/3 of the pre-specified remote monitoring study components
次要结局
未报告次要终点