跳至主要内容
临床试验/NCT02895841
NCT02895841已完成不适用

Patient-Empowered Mobile Technology in Hospitalized Patients: Technology Resources to Understand Pain Assessment in Patients With Pain (TRU-PAIN)

Duke University2 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2016年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
174
试验地点
2
主要终点
time to discontinuation of the IV PCA with opioid medication

研究概览

简要总结

The purpose of this study is to learn more about the ways in which mobile technology can be integrated into inpatient care to help better track pain levels using mobile technology of patients with sickle cell disease, oncology patients, and bone marrow transplant patients. The study will assess whether or not daily mobile monitoring with wearable accelerometers (devices that detect movement as well as heart-rate) to monitor and manage medical treatments can have a lasting positive impact on outcomes in patients with chronic diseases. The investigator hopes to learn more about the ways in which mobile technology can be integrated into inpatient care. Specifically, the investigator is looking to help patients better track their pain, use wearable technology to track physiological measures (for example, heart rate, sleep quantity and quality), and integrate these data points into the medical care of patients by providing the information to providers. This study will first gather information regarding the feasibility and acceptability of the use of technology on the inpatient unit. This will help the study team to refine the technology of the mobile app and logistics of integration. Following this, the investigator will complete a second phase of the study, during which select patients will pilot the intervention. This will be followed by the third and final phase, during which patients will be randomly assigned to the active intervention or standard of care. This phase approach will enable the study team to refine the intervention, relying on the feedback from patients and providers, and subsequently test its utility compared to standard of care through random assignment.

详细描述

The investigator hopes to learn more about the ways in which mobile technology can be integrated into inpatient care. Specifically, the investigator is looking to help patients better track their pain, use wearable technology to track physiological measures (for example, heart rate, sleep quantity and quality), and integrate these data points into the medical care of patients by providing the information to providers. This study will first gather information regarding the feasibility and acceptability of the use of technology on the inpatient unit. This will help the study team to refine the technology of the mobile app and logistics of integration. Following this, the investigator will complete a second phase of the study, during which select patients will pilot the intervention. This will be followed by the third and final phase, during which patients will be randomly assigned to the active intervention or standard of care. This phase approach will enable the study team to refine the intervention, relying on the feedback from patients and providers, and subsequently test its utility compared to standard of care through random assignment.

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
8 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any patient 8-80 years old with a past medical history for a chronic disease (such as sickle cell disease), cancer (solid tumor, lymphoma, brain tumor), or currently undergoing bone marrow transplant
  • Currently admitted to the hospital
  • Have a current diagnosis which includes pain for which they are being treated

排除标准

  • Must be enrolled within 48 hours of admission
  • Due to the possibility of a choking hazard, only patients who are at least 8 years of age will be enrolled in the study
  • Patients in the Intensive Care Units will not be eligible
  • Must be able to understand and operate the mobile device independently; therefore the investigators will exclude those the provider team considers unable to do so

结局指标

主要结局

time to discontinuation of the IV PCA with opioid medication

时间窗: 7 days

次要结局

  • time of movement during hospitalization(7 days)
  • magnitude of change in pain scores(7 days)
  • patient/family satisfaction scores as measured by feasibility survey(7 days)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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