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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Usability of virtual agent vs. human agent for onboarding patients to RPM devices as assessed by the System Usability Scale (SUS)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Human agent
Intervention: Human agent (Other)
Virtual agent
Intervention: Virtual agent (Device)
Outcomes
Primary Outcomes
Usability of virtual agent vs. human agent for onboarding patients to RPM devices as assessed by the System Usability Scale (SUS)
Time Frame: 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.
Secondary Outcomes
- 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)