Conversational Agents to Improve Quality of Life in Palliative Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 367
- 试验地点
- 1
- 主要终点
- Quality of Life of palliative cancer care participants
研究概览
简要总结
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:
- medication counseling;
- physical activity promotion;
- symptom management and continual screening for adverse events; and
- alleviation of stress and anxiety
- spiritual needs assessment; and
- 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.
详细描述
Pilot Study The pilot study will determine usability of the ECA tablet system. Healthy volunteers will be recruited at Northeastern University, where the system is being developed. Subjects will spend approximately 60 minutes with the tablet system and provide usability feedback. Twelve healthy patient volunteers will be recruited to review the system as well as provide feedback on the relative interview burden (was the interview too long, too invasive, etc). No identifiable data will be collected from pilot study subjects.
Main Study The study will consist of adults with advanced illness (health care provider endorses the existence of a potentially life-limiting condition and endorses that "it would not be a surprise if the patient died within 12 months") who will be randomized to intervention or usual care control groups. Each person with an advanced illness will be enrolled along with a caregiver (i.e., family, friend) who will serve as a surrogate subject. The caregiver will be consented at baseline and interviewed at that point and at the final, 6-month study visit. In addition, if, at any point during their enrollment in the study, the patient-subject becomes unable, or decisionally impaired, to answer interview questions, the caregiver will be asked to answer on behalf of the subject.
The patient can be found to be decisionally impaired in any of 3 ways:
- the patient declares themselves to be unable to answer questions appropriately
- the patient is unable to pass a brief cognitive assessment that will be administered at the beginning of each telephone follow-up (per the Brief Screen for Cognitive Impairment)
- the patient is physically unable to answer questions on the phone (due to, for example, serious health decline or death)
Baseline data will be collected after enrollment and before randomization. Baseline data includes:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21 years of age or older
- •English speaking
- •Able to independently consent to be in the study
- •Has adequate corrected vision to be able to use the ECA system (based on a 1-minute ECA functional screener)
- •Has adequate hearing to be able to use the ECA system (headphones will be available)
- •Has a health care provider who endorses the existence of a potentially life-limiting condition and endorses that it would not be a surprise if the patient died within 12 months (PATIENT-SUBJECTS only)
排除标准
- •Enrolled in hospice
- •Already being followed by the Palliative Care team
- •Suicidal or homicidal
- •In police custody
- •Do not live in the Boston area
- •Plan on leaving the Boston area for more than 4 weeks in the next 6 months
- •Not able to use the ECA tablet computer
研究组 & 干预措施
Control Usual Care
In this arm the subject receives usual care and just completes the baseline interview, monthly telephone surveys about their quality of life, and the exit interview at 6 months after enrollment.
Embodied Conversational Agent (ECA)
In this arm the subject is trained how to use a tablet device which they take home for the duration of the study. These subjects complete the baseline interview, monthly telephone surveys about their quality of life, and the exit interview at 6 months after enrollment.
干预措施: Embodied Conversational Agent (ECA) (Behavioral)
结局指标
主要结局
Quality of Life of palliative cancer care participants
时间窗: assessed monthly up to 6 months
QOL will be assessed using QLQ-C15-PAL, a 15-scale-item instrument designed to assess the quality of life of participants.
次要结局
- Palliative Care services utilization(assessed monthly up to 6 months)
- Hospital utilization(assessed at 6 months)
- Cost(assessed at 6 months)
- Mental health(assessed at enrollment and at 6 months)
- Patient activation(assessed at enrollment and at 6 months)
- Medication adherence(assessed at enrollment and at 6 months)
- Symptoms(assessed at enrollment and at 6 months)
- Advance Care Planning and preferences(assessed at enrollment and at 6 months)
- Spiritual Needs(assessed at enrollment and at 6 months)
- Medical Orders for Life-Sustaining Treatment (MOLST) completion rate(assessed at enrollment and at 6 months)
- Social health(assessed at enrollment and at 6 months)
- Physical activity(assessed at enrollment and at 6 months)
- Satisfaction with the ECA-PAL system(assessed at 6 months)
- Use of the ECA-PAL system by subjects in the intervention group(assessed at 6 months)