Using Innovative Communication Technology to Improve the Health of Young African American Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 528
- 试验地点
- 1
- 主要终点
- Reduction in Number of Preconception Risks
研究概览
简要总结
This study is to examine the effectiveness of a health communication system (Gabby) that assesses preconception health risks and tailors the education and intervention to each subject, based on her health risks. This project specifically targets young Black or African American women in order to reduce major disparities in birth outcomes. Clinicians do not have time to assess for the over 100 preconception health risks that can impact birth outcomes; the investigators system can streamline that assessment and create a personalized list of risks. Patients can then share their list with clinicians to make their healthcare visits more effective.
The investigators will conduct a two-armed randomized controlled trial (RCT) designed to enroll 530 African American women ages 18-34. After all subjects complete a comprehensive preconception health risk assessment, the intervention group will be trained to use the Gabby system and encouraged to use it at least monthly for one year. The control group will receive a letter listing the risks identified and they will be encouraged to see their clinician to discuss them.
The investigators primary hypothesis will test whether the Gabby system will result in a lower rate of preconception health risks, as defined by CDC, as compared to the control group after 12 months. Secondary outcomes include: measurement of usage rates, dose of exposure, attrition, subject and healthcare provider satisfaction, and number of women with a personalized health plan.
详细描述
The investigators will conduct a two-armed randomized controlled trial designed to enroll 530 African American women ages 18-34. After all subjects complete enrollment forms a comprehensive preconception health risk assessment, the intervention group will be trained to use the Gabby system and encouraged to use it at least monthly for one year.The control group will receive a letter listing the risks identified and they will be encouraged to see their clinician to discuss them.
System Preparation: Dr. Bickmore and the technical team will be responsible for preparing the system for the trial, using the preconception care content and scripts developed by Dr. Jack and the research team. Both teams will meet as the working group to discuss final preparation and modifications.
Usability Testing: As software development is complete, the investigators will conduct thorough usability testing of the interventions and the RCT protocols, using approximately 20 subjects who meet the enrollment criteria of the study. The subjects will use the Gabby system in the investigators research offices to complete the health risk assessment and to begin the interaction about individual risk factors. This session will last no more than one hour. Then they will use the Gabby system online in their home for two weeks; their interactions with the system will include: learning about their individual preconception health risks, managing their "My Health To-Do List," writing stories about their experiences with their health risks, and listening to stories left by other users. Usability subjects will be given a structured log sheet that lists each part of the intervention with space for them to record their reactions and concerns. Research staff (including representatives of both the technical and clinical staff) will review the log sheets. Then individual interviews examining their perceptions of the Gabby system will be conducted by Dr.Yinusa-Nyahkoon using a semi-structured interview guide (see attached Semi-Structured Interview Guide). Dr. Yinusa-Nyahkoon will recommend design and content changes based on interviews. These usability-testers will be paid for their participation and will not participate in the RCT. The investigators anticipate needing to implement a round of system modifications based on subject feedback.
RCT: All RCT participants will be screened for eligibility criteria (see section 21), give consent to participate, and complete baseline data collection forms, including the online Preconception Health Risk Assessment.
Randomization. Using a random numbers table, the statistician (Dr. Chetty) will prepare a numbered set of sealed study allocation envelopes prior to study start. Block randomization will be used to ensure that an equal number of subjects are randomized in each age group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 34 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 18-34
- •Self-identify as Black or African American
- •Have a phone and are willing to receive study-related phone calls
- •Have access to a computer with internet
排除标准
- •Do not speak English
- •Self-reported pregnant at the time of enrollment
研究组 & 干预措施
Intervention (Virtual Patient Advocate)
The Intervention Virtual Patient Advocate (VPA) Group participants will be given a username and secure password to log on to the Gabby site for the 12 months of the intervention. They will be encouraged to log on every two weeks or twice a month, but using the system is voluntary. They will be given the contact information of the Program Manager in the event that they have any issues or questions about the system. The research team will call each intervention participant after 6 and 12 months to conduct a follow-up phone call to collect outcome data. At the end of the intervention period, intervention participants will be invited to participate a focus group session.
干预措施: Virtual Patient Advocate (VPA) (Behavioral)
Control (Letter)
The control group will receive a letter listing the preconception risks identified in the risk assessment and they will be encouraged to see their clinician to discuss them.
结局指标
主要结局
Reduction in Number of Preconception Risks
时间窗: Baseline and at 12 months after enrollment
Our primary hypothesis will test whether the Gabby system will result in a lower rate of preconception health risks, as defined by CDC, as compared to the control group after 12 months.
次要结局
- Dose of Exposure to Virtual Patient Advocate (VPA) System(12 months after enrollement (data gathered by online system throughout the 12 month intervention period))
- Subject Satisfaction with Virtual Patient Advocate (VPA) system(12 months after enrollment)
- Healthcare Provider Satisfaction(Following the participant's appointment with a primary care provider, at any point during the 12 month intervention period)
研究者
Brian Jack
Professor and Chair
Boston Medical Center