跳至主要内容
临床试验/NCT02965651
NCT02965651已完成不适用

A Randomized Controlled Trial of A Virtual Patient Advocate System: "Go to Gabby" for Health and Wellness Information

Boston Medical Center2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2015年1月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paula Gardiner

Associate Professor

Boston Medical Center

研究点 (2)

Loading locations...

相似试验