Implementation of Digital Vital Sign Monitoring to Decrease Sleep Interruption and Enhance Recovery in Phase II of the PROmoting Sleep, Patient Engagement and Recovery (PROSPER) Project
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Quality of Life Questionnaires (EuroQol Group EQ-5D)
研究概览
简要总结
This phase II/III trial examines how a sleep enhancement intervention, including the use of wearable digital vital sign monitoring device (ViSi), affects the quality of life of cancer patients receiving acute care. Sleep enchancement interventions may improve the quality of life of patients with cancer due to fewer interruptions at night during hospital stays.
详细描述
Objective
Primary Objective:
1). Investigate the impact of our sleep enhancement intervention, that entails a wearable digital vital sign monitoring device, on variation in the quality of life of acute care cancer patients
Secondary Objectives:
- . Assess the impact of our sleep enhancement intervention on acute care utilization e.g. length of stay, 30-day readmissions
- . Assess the implementation and feasibility of wearable digital vital signs capture in an inpatient oncologic setting using validated instruments such as system usability scale (SUS) and Weiner implementation outcomes (AIM, FIM, IAM).
- . Assess the impact, via validated survey instruments, of our sleep enhancement intervention on patient mood, patient activation and satisfaction with inpatient stay experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Adult patients (> 18 years of age), english speaking, able to complete consent and survey materials.
- •Patients must be admitted to the hospital for at least 3 nights.
- •Patient's using pharmacological sleeping aides will be included in the study as this will help us understand if the intervention will also help patients with pre-exisitng sleep disturbances.
排除标准
- •Vulnerable populations (pregnancy, incarcerated, history of delirium, suicidal ideation, ischemic stroke with measurable neurologic deficit, cerebral palsy, seizures), primary brain tumor/metastases patients.
- •Patients concurrently enrolled in contact isolation with SARS-CoV2 will be excluded.
- •Lastly, hospice or hospice-bound patients will also be excluded.
- •Any patient can remove themselves from the study at any point.
研究组 & 干预措施
Intervention group
Participants will receive sleep enhancement intervention and will wear the ViSi Mobile device.
干预措施: ViSi Mobile device (Device)
Control group
Participants will receive sleep enhancement intervention only. Participants in the control group will not wear the ViSi Mobile device.
干预措施: Sleep enhancement intervention (Drug)
结局指标
主要结局
Quality of Life Questionnaires (EuroQol Group EQ-5D)
时间窗: through study completion, an average of 1 year
Score Scales (0-100) 0-worst health/100 best health
次要结局
未报告次要终点