A Randomized Trial of Roadmap 2.0
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 372
- 试验地点
- 2
- 主要终点
- Caregiver health-related quality of life (HRQOL) assessed by the PROMIS Global Health scale.
研究概览
简要总结
The purpose of this research study is to measure the effects of using a mobile phone app (Roadmap 2.0) on the health-related quality of life of caregivers and patients undergoing allogeneic/autologous hematopoietic cell transplantation (HCT).
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). Roadmap 2.0 is a web-based application that integrates patient-specific information and includes several domains: laboratory results, medications, clinical trial details, photos of the healthcare team, trajectory of transplant process, and discharge checklist.
This trial is anticipated to enroll 664 participants, but only caregivers (332 total) will be evaluated for the primary and secondary outcome measures. Thus, the sample size is 332. The total enrollment includes 166 caregiver-patient dyads of adult patients (age >/=18 years) undergoing HCT ("adult dyads" = 332 total) and 166 caregiver-patient dyads of pediatric patients (age 5-17 years) undergoing HCT ("pediatric dyads" = 332 total).
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
- 5 Years 至 75 Years（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 (see 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).
- •An eligible patient is age ≥5 years.
- •An eligible patient is scheduled to undergo HCT.
- •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 and also in accordance to institutional guidelines. A patient is able to undergo HCT at the U-M only if a designated family caregiver (e.g., parents, adult children, spouses, family members, neighbors, friends) accepts the roles, in accordance to the Clinical Practice Guidelines of the U-M BMT Program.
- •The caregiver and patient must have his/her own smartphone to participate.
排除标准
- •- Patient does not meet eligibility criteria to undergo HCT at the U-M BMT Program or Oregon Health & Sciences University.
研究组 & 干预措施
Roadmap 2.0
Roadmap 2.0 mobile app + wearable sensor to track activity and sleep + usual care (informational or educational resources provided through verbal communication or written hand-out materials).
Includes caregivers of adult patients and caregivers of pediatric patients
干预措施: Wearable activity sensor (Other)
Roadmap 2.0
Roadmap 2.0 mobile app + wearable sensor to track activity and sleep + usual care (informational or educational resources provided through verbal communication or written hand-out materials).
Includes caregivers of adult patients and caregivers of pediatric patients
干预措施: Roadmap 2.0 information system (Behavioral)
Roadmap 2.0
Roadmap 2.0 mobile app + wearable sensor to track activity and sleep + usual care (informational or educational resources provided through verbal communication or written hand-out materials).
Includes caregivers of adult patients and caregivers of pediatric patients
干预措施: Survey administration (Other)
Roadmap 2.0 with Positive Activities
Roadmap 2.0 mobile app (patients), Roadmap 2.0 with mobile Positive Activities app (caregivers) + wearable sensor to track activity and sleep + usual care (informational or educational resources provided through verbal communication or written hand-out materials).
Includes caregivers of adult patients and caregivers of pediatric patients
干预措施: Survey administration (Other)
Roadmap 2.0 with Positive Activities
Roadmap 2.0 mobile app (patients), Roadmap 2.0 with mobile Positive Activities app (caregivers) + wearable sensor to track activity and sleep + usual care (informational or educational resources provided through verbal communication or written hand-out materials).
Includes caregivers of adult patients and caregivers of pediatric patients
干预措施: Roadmap 2.0 information system with Positive Activities (Behavioral)
Roadmap 2.0 with Positive Activities
Roadmap 2.0 mobile app (patients), Roadmap 2.0 with mobile Positive Activities app (caregivers) + wearable sensor to track activity and sleep + usual care (informational or educational resources provided through verbal communication or written hand-out materials).
Includes caregivers of adult patients and caregivers of pediatric patients
干预措施: Wearable activity sensor (Other)
结局指标
主要结局
Caregiver health-related quality of life (HRQOL) assessed by the PROMIS Global Health scale.
时间窗: At day 120 post-transplant
Mean Global Health scores for each arm at day 120. PROMIS® instruments are scored using item-level calibrations. This method of scoring uses "response pattern scoring," which uses responses to each item for each participant.
Caregiver Health-related Quality of Life (HRQOL) Assessed by the PROMIS Global Health Scale.
时间窗: At day 120 post-transplant
Mean Global Health scores for each arm at day 120. PROMIS® instruments are scored using item-level calibrations. This method of scoring uses "response pattern scoring," which uses responses to each item for each participant. Scores generally range from 20 to 80, with higher scores indicating better health.
次要结局
未报告次要终点