A Randomized Pilot Study Comparing the Feasibility of Using a Virtual Agent vs. an Off-site Human Agent to Onboard Oncology Patients to a Remote Monitoring Device
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Usability of virtual agent vs. human agent for onboarding patients to RPM devices as assessed by the System Usability Scale (SUS)
研究概览
简要总结
The purpose of this study is to compare the use of a virtual agent vs. a human agent when onboarding oncology patients over the telephone to Remote Patient Monitoring (RPM) devices. RPM devices are instruments that a patient can use to measure their own weight and vital signs. Both the virtual and human agents will be available by telephone to instruct the patient on how to use the RPM devices to measure weight, blood pressure, heart rate, temperature, and oxygen saturation. Patients will be randomized to either the virtual or human agent, have assessments of their medical and oncological history, overall well-being, body measurements, and vital signs, and will complete questionnaires about their experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information.
- •Cancer (solid tumor)
- •Planning to return to Duke Cancer Center clinic for three days in a row
- •Patients whose treatment does not require that they return to clinic for three days in a row, but who are willing to voluntarily return to participate in this study are permitted to enroll.
- •Eastern Cooperative Oncology Group (ECOG) score of 0-2
- •Native fluency of spoken English as determined by the investigator
- •Non-native English speakers are permitted to enroll if they have achieved native fluency.
- •Vitals as collected by the clinic using Duke maintained equipment must be within the ranges specified by the remote patient monitoring devices.
- •Weight ≤ 180 kg
- •Systolic blood pressure ≤ 300 mmHg
- •Pulse rate of 40-200 bpm
- •SpO2 of 70-100%
- •Temperature 34.0-42.2°C
- •Arm circumference of 22-42 cm
排除标准
- •1. Vision, speech, auditory, physical, cognitive or other impairment that has the potential to interfere with the use of the remote patient monitoring device or agent, in the opinion of the investigator or study coordinator.
- •Has an implanted pacemaker, arterio-venus (A-V) shunt, a history of mastectomy or lymph node clearance, history of severe blood flow problems or blood disorders, or a history of severe circulatory deficit in the arm.
- •Is pregnant
研究组 & 干预措施
Human agent
干预措施: Human agent (Other)
Virtual agent
干预措施: Virtual agent (Device)
结局指标
主要结局
Usability of virtual agent vs. human agent for onboarding patients to RPM devices as assessed by the System Usability Scale (SUS)
时间窗: Day 1, Day 2, Day 3
The SUS is a questionnaire that assesses perceived usability. It includes 10 five-point items with alternating positive and negative tone. The final score is a number 0-100 with a higher score indicating better usability.
次要结局
- Description of the patient experience when using a virtual agent in the context of teaching a patient as assessed by the patient experience survey.(Day 3)
- Identification of opportunities to improve the use of a virtual agent in the context of teaching a patient as assessed by the patient experience survey.(Day 3)
- Description of the patient experience when using a virtual agent in the context of teaching a patient as assessed by the patient experience survey.(Day 3)
- Identification of opportunities to improve the use of a virtual agent in the context of teaching a patient as assessed by the patient experience survey.(Day 3)