Conversational Agents to Improve Quality of Life in Palliative Care

NCT02750865 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 367

Last updated 2023-07-13

No results posted yet for this study

Summary

In this study the investigators will advance research on the development of easy to use technologies to empower patients. This is a scalable approach that has a significant potential to reduce suffering for palliative care patients and their caregivers. The investigators will adapt existing tested empathic conversational agents (ECA) for home-based cancer care management and inpatient bedside counseling to provide the following functions:

1. medication counseling;
2. physical activity promotion;
3. symptom management and continual screening for adverse events; and
4. alleviation of stress and anxiety
5. spiritual needs assessment; and
6. advanced care planning.

Data from the system will be monitored by a health professional, who communicates with members of the patient's care team. In this project, this activity will include facilitating referral for palliative care services.

The investigators will conduct pilot studies both at Boston Medical Center and at Northeastern University that will test system usability (Northeastern University and BMC) as well as interview burden (BMC only).

The investigators will conduct a Randomized Control Trial (RCT) to evaluate the agent technology, comparing usual care (UC) versus usual care plus the agent (UC+ECA) for patients 21 or older, with a life expectancy of \< 1 year, from outpatient clinics at Boston Medical Center (BMC). Each subject will be enrolled along with a caregiver surrogate subject. In addition to baseline data collection, there will be monthly phone surveys for six months; intervention subjects will use the system for a six-month period of time. In addition, the investigators will conduct a randomized trial within the intervention group to compare subjects getting functions 1-4 (above) versus subjects getting the augmented intervention with all six functions. The intervention will include a nurse management interface to monitor clinical alerts generated by the system to stimulate interventions by the clinical staff.

Conditions

  • Palliative Care

Interventions

BEHAVIORAL

Embodied Conversational Agent (ECA)

The ECA is a computer generated character who will interact with the subject on a daily basis via a touch-screen tablet. The system is designed to provide the following functions: (1) medication counseling; (2) physical activity promotion; (3) symptom management and continual screening for adverse events; and (4) alleviation of stress and anxiety. The investigators will augment the system to include: (5) spiritual needs assessment; and (6) advanced care planning.

Sponsors & Collaborators

  • Northeastern University

    collaborator OTHER
  • Boston University

    collaborator OTHER
  • National Institute of Nursing Research (NINR)

    collaborator NIH
  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Julien Dedier, MD · Boston Medical Center

  • Michael Paasche-Orlow, MD, MPH · Tufts Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-02
Primary Completion
2022-10-24
Completion
2022-10-24

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02750865 on ClinicalTrials.gov