A Randomized Controlled Trial of A Virtual Patient Advocate System: "Go to Gabby" for Health and Wellness Information
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Number of participants whom outcome data can be collected
研究概览
简要总结
The purpose of this randomized controlled trial is to evaluate the feasibility of introducing an innovative eHealth technology, the Embodied Conversational Agent (ECA), to diverse women from an urban outpatient setting.
详细描述
This trial focuses on using an embodied conversational agent (ECA) named Gabby to teach healthy lifestyle behaviors (healthy eating, exercise, stress reduction). This feasibility randomized control trial will include 70 women in the outpatient setting (35 intervention and 35 controls). The control group will receive usual care (patient information sheets on healthy eating, exercise, stress reduction and a CD with meditation, body scan, and mindful yoga).
The ECA is an animated conversational character who simulates face-to-face interaction with a patient. During the intervention, the ECA talks using synthetic speech and synchronized animation; patients "talk" by clicking what they want to say using a computer's mouse. The ECA delivers information and experiential on stress (principles of mindfulness based stress reduction such as: meditation, yoga, body scan), nutrition, and exercise.
If participants are randomized to the intervention, a research assistant (RA) will teach the subject how to use the ECA workstation. The ECA will review with the patients their nutrition, stress, exercise, using the ECA workstation which will also be programmed with the subject's baseline information (e.g., name, age). Subjects will be asked to log onto the system once a day and interact with the system for as long as they wish.
Prior to the midpoint survey, participants will receive a reminder phone call/email. At 14 days, the RA will survey all participants regarding satisfaction with either the ECA or the paper handouts, and whether or not they are adhering to the lifestyle modification recommendations. This will be conducted either by email, phone or in person.
Prior to the end of the 30 day study participation, the RA will call or email to schedule a visit to complete the post intervention questionnaire. The RA will call/email 1-2 days before the final study visit to remind the participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •English fluency sufficient to follow treatment instructions and answer survey questions
- •Access to a telephone (landline, cellular phone)
- •Access to a computer/laptop with internet/Wi-Fi access
排除标准
- •Known or planned pregnancy
- •Mental health or substance abuse problems that would bar completion of study
- •Refusal of consent
结局指标
主要结局
Number of participants whom outcome data can be collected
时间窗: 1 month
Number of people recruited
时间窗: 1 year
Number of participants who were racial minorities (non-white)
时间窗: 1 month
Number of participants who completed the study
时间窗: 1 month
Participant satisfaction with either treatment arm
时间窗: 1 month
Likert scale of 1-7 (1=not satisfied, 7=very satisfied)
次要结局
- Depression(1 month)
- Stress Level(1 month)
- Dietary Patterns(1 month)
- Food Access(1 month)
- Duration of ECA Use(1 month)
- Education Level(1 month)
- BMI(1 month)
- Health Conditions(1 month)
- Pain Levels(1 month)
- Number of Logins into the ECA(1 month)
- Work Status(1 month)
- Ethnicity(1 month)
- Technical issues(1 month)
- Age(1 month)
- Race(1 month)
- Medication Use(1 month)
- Smoking Status(1 month)
- Physical Activity(1 month)
- Income Level(1 month)
研究者
Paula Gardiner
Associate Professor
Boston Medical Center
