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

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information.

• Age ≥18

• 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

Locations
United States
North Carolina
Duke University Medical Center
RECRUITING
Durham
Contact Information
Primary
Laura Alder, MD
laura.alder@duke.edu
919-862-5400
Time Frame
Start Date: 2025-09
Estimated Completion Date: 2026-08
Participants
Target number of participants: 36
Treatments
Experimental: Virtual agent
Active_comparator: Human agent
Related Therapeutic Areas
Sponsors
Leads: Duke University

This content was sourced from clinicaltrials.gov