Clinical trial NCT06682013: Virtual Agent Feasibility in Oncology Patients (NTT Data)
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

1. Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information.
2. Age ≥18
3. Lung cancer
4. 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.
5. Eastern Cooperative Oncology Group (ECOG) score of 0-2
6. Native fluency of spoken English as determined by the investigator

   * Non-native English speakers are permitted to enroll if they have achieved native fluency.
7. 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
8. Arm circumference of 22-42 cm

Exclusion Criteria:

1. Vision, speech or auditory impairment that has the potential to interfere with the use of the remote patient monitoring device or agent, in the opinion of the investigator.
2. 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.
3. Is pregnant
4. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the investigator.

Primary outcomes:
measure: Usability of virtual agent vs. human agent for onboarding patients to RPM devices as assessed by the System Usability Scale (SUS)
timeFrame: Day 1, Day 2, Day 3
Secondary outcomes:
measure: Effectiveness of RPM devices when onboarded by virtual agent vs. human agent as assessed by a significant difference in measured weight collected by the study coordinator and the participant using the RPM devices compared across both arms.
timeFrame: Day 1, Day 2, Day 3
measure: Effectiveness of RPM devices when onboarded by virtual agent vs. human agent as assessed by a significant difference in measured blood pressure collected by the study coordinator and the participant using the RPM devices compared across both arms.
timeFrame: Day 1, Day 2, Day 3
measure: Effectiveness of RPM devices when onboarded by virtual agent vs. human agent as assessed by a significant difference in measured heart rate collected by the study coordinator and the participant using the RPM devices compared across both arms.
timeFrame: Day 1, Day 2, Day 3
measure: Effectiveness of RPM devices when onboarded by virtual agent vs. human agent as assessed by a significant difference in measured temperature collected by the study coordinator and the participant using the RPM devices compared across both arms.
timeFrame: Day 1, Day 2, Day 3
measure: Effectiveness of RPM devices when onboarded by virtual agent vs. human agent as assessed by a significant difference in measured oxygen saturation collected by the study coordinator and the participant using the RPM devices compared across both arms.
timeFrame: Day 1, Day 2, Day 3
measure: Description of the patient experience when using a virtual agent in the context of teaching a patient as assessed by the patient experience survey.
timeFrame: Day 3
measure: 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.
timeFrame: Day 3
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Laura Alder, MD
role: PRINCIPAL_INVESTIGATOR
References: