Promoting Health and Well-Being Through Mobile Health Technology (Roadmap 2.0) in Family Caregivers and Patients Undergoing Hematopoietic Stem Cell Transplantation: Protocol for the Development of a Mobile Randomized Controlled Trial.
Promoting Health and Well-Being Through Mobile Health Technology (Roadmap 2.0) in Family Caregivers and Patients Undergoing Hematopoietic Stem Cell Transplantation: Protocol for the Development of a Mobile Randomized Controlled Trial.
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DOI：
10.2196/19288
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发表时间：
2020-09-18
影响因子：
1.7
通讯作者：
Choi SW
中科院分区：
文献类型：
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作者：
Rozwadowski M;Dittakavi M;Mazzoli A;Hassett AL;Braun T;Barton DL;Carlozzi N;Sen S;Tewari M;Hanauer DA;Choi SW
接受同种异体造血干细胞移植的癌症患者是医学上最脆弱的患者群体之一，对护理人员的需求极大。事实上，随着出院人数的增加，对护理人员的需求继续增加。此外，世界范围内异体造血干细胞移植的数量正在增加，这种昂贵的手术具有重大的经济后果。因此，家庭照顾者的健康和福祉引起了广泛的关注。移动卫生技术已被证明能够提供灵活、省时和节约成本的干预措施，以支持整个护理过程中的家庭护理人员。该协议旨在利用技术提供一种名为路线图2.0的新型面向护理人员的移动卫生干预措施。我们将评估路线图2.0在接受造血干细胞移植患者的家庭护理人员中的有效性。路线图2.0干预将包括一项移动随机试验，比较积极心理干预组和对照组在家庭照顾者-患者二人组中的差异。主要结局将是护理者与健康相关的生活质量，在移植后第120天通过PROMIS全球健康量表进行评估。次要结果将包括其他PROMIS护理者和患者报告的结果，包括陪伴、控制症状的自我效能、管理日常活动的自我效能、积极影响和幸福感、睡眠障碍、抑郁和焦虑。在研究结束时，将对参与者进行半结构化的定性访谈。我们还将通过可穿戴手腕传感器测量客观生理指标（如睡眠、活动、心率），并通过电子健康记录测量医疗保健利用数据。我们计划招募166对家庭护理者-患者进行完整的数据分析。该研究已获得机构审查委员会的批准，以及我们的健康信息技术服务部门的代码审查和信息保障批准。由于COVID-19大流行，这项研究被暂时搁置。然而，招聘于2020年8月开始。我们已将所有招聘、注册和入职流程转换为通过视频远程医疗远程进行。同意将通过Roadmap 2.0应用程序以电子方式获得。这项移动随机试验将确定通过移动健康技术提供的基于积极心理学的活动是否可以在16周的研究期间改善护理者与健康相关的生活质量。这项研究将为可穿戴式手腕传感器对护理人员和患者自我报告结果的影响提供额外的数据。ClinicalTrials.gov NCT04094844;https://www.clinicaltrials.gov/ct2/show/NCT04094844 prr1 - 10.2196/19288
Cancer patients who undergo allogeneic hematopoietic stem cell transplantation are among the most medically fragile patient populations with extreme demands for caregivers. Indeed, with earlier hospital discharges, the demands placed on caregivers continue to intensify. Moreover, an increased number of allogeneic hematopoietic stem cell transplantations are being performed worldwide, and this expensive procedure has significant economic consequences. Thus, the health and well-being of family caregivers have attracted widespread attention. Mobile health technology has been shown to deliver flexible, and time- and cost-sparing interventions to support family caregivers across the care trajectory. This protocol aims to leverage technology to deliver a novel caregiver-facing mobile health intervention named Roadmap 2.0. We will evaluate the effectiveness of Roadmap 2.0 in family caregivers of patients undergoing hematopoietic stem cell transplantation. The Roadmap 2.0 intervention will consist of a mobile randomized trial comparing a positive psychology intervention arm with a control arm in family caregiver-patient dyads. The primary outcome will be caregiver health-related quality of life, as assessed by the PROMIS Global Health scale at day 120 post-transplant. Secondary outcomes will include other PROMIS caregiver- and patient-reported outcomes, including companionship, self-efficacy for managing symptoms, self-efficacy for managing daily activities, positive affect and well-being, sleep disturbance, depression, and anxiety. Semistructured qualitative interviews will be conducted among participants at the completion of the study. We will also measure objective physiological markers (eg, sleep, activity, heart rate) through wearable wrist sensors and health care utilization data through electronic health records. We plan to enroll 166 family caregiver-patient dyads for the full data analysis. The study has received Institutional Review Board approval as well as Code Review and Information Assurance approval from our health information technology services. Owing to the COVID-19 pandemic, the study has been briefly put on hold. However, recruitment began in August 2020. We have converted all recruitment, enrollment, and onboarding processes to be conducted remotely through video telehealth. Consent will be obtained electronically through the Roadmap 2.0 app. This mobile randomized trial will determine if positive psychology-based activities delivered through mobile health technology can improve caregiver health-related quality of life over a 16-week study period. This study will provide additional data on the effects of wearable wrist sensors on caregiver and patient self-report outcomes. ClinicalTrials.gov NCT04094844; https://www.clinicaltrials.gov/ct2/show/NCT04094844 PRR1-10.2196/19288