A Pilot Study of Roadmap 2.0 in Oncology Caregivers and Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Enrollment rate
研究概览
简要总结
This study will investigate the use of a mobile health app (Roadmap 2.0) intervention in caregivers of patients with cancer. In this study participants will be given the Roadmap 2.0 app, with a focus on the positive aspects of caregiving (positive activity components), and a Fitbit. The primary objective of this pilot study is to test the feasibility and acceptability of using the mobile health app.
详细描述
Health information technology tools may enable caregivers and patients to become more active participants in their healthcare.This study is not to provide any treatment, but rather to investigate the use of this mobile health technology-mediated intervention (Roadmap 2.0).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The caregiver must have an eligible patient (defined in items 5 - 9, below)
- •The caregiver must be of age ≥18 years.
- •The caregiver should be comfortable in reading and speaking English and signing informed consents.
- •The caregiver should provide at least 50% of care needs.
- •An eligible patient is one who identifies the eligible caregiver as their primary caregiver (i.e., provides at least 50% of care needs). The caregiver who provides consent will be deemed the caregiver who participates in the study. In adolescents who are at the age to provide assent, she/he will designate the caregiver who provides >50% of their care, and that caregiver will sign the consent document.
- •An eligible patient is age ≥5 years.
- •An eligible patient is able to sign informed consent/assent forms.
- •Patients and caregivers agree to provide informed consent that is in regulatory compliance and IRBMED-approved.
- •The caregiver and patient must have his/her own smartphone or tablet to participate.
排除标准
- 未提供
研究组 & 干预措施
Roadmap 2.0 + Fitbit Charge 3
- Caregivers and patients download the Roadmap 2.0 mobile app on their own mobile phones or tablet to use freely throughout the 120 day study period.
- Caregivers and patients receive a Fitbit wearable activitiy sensor to track activity and sleep.
干预措施: Roadmap 2.0 information system (Behavioral)
Roadmap 2.0 + Fitbit Charge 3
- Caregivers and patients download the Roadmap 2.0 mobile app on their own mobile phones or tablet to use freely throughout the 120 day study period.
- Caregivers and patients receive a Fitbit wearable activitiy sensor to track activity and sleep.
干预措施: Wearable activity sensor (Other)
Roadmap 2.0 + Fitbit Charge 3
- Caregivers and patients download the Roadmap 2.0 mobile app on their own mobile phones or tablet to use freely throughout the 120 day study period.
- Caregivers and patients receive a Fitbit wearable activitiy sensor to track activity and sleep.
干预措施: Survey administration (Other)
结局指标
主要结局
Enrollment rate
时间窗: At time of enrollment
Percentage of participants (caregivers and patients) enrolled in the study, of the total number approached for enrollment. Qualitative and quantitative analysis will be conducted.
Roadmap 2.0 login rate
时间窗: Day 120
Percentage of participants (caregivers and patients) who login to Roadmap 2.0 at least 2 times per week for at least 50% of the study duration (120 days). Login data will be collected by the Roadmap 2.0 software. Qualitative and quantitative analysis will be conducted.
次要结局
- Survey completion rate(Day 120)