eFramingham Heart Study Randomized Controlled Trial #2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 492
- 试验地点
- 1
- 主要终点
- Proportion of Surveys/Tasks Returned in Period 4
研究概览
简要总结
In the electronic Framingham Heart Study (eFHS), the investigators developed and deployed a mobile app to collect cardiovascular risk factors and event data and test them against cardiovascular data collected in the Framingham research clinic for the FHS.
Participants enrolled in eFHS receive a series of digital surveys modules to complete on a regularly occurring schedule. The objective of the planned randomized trial is to test the effect of administering half of survey modules every 2 weeks versus all survey modules every 4 weeks on improving participants' response rates.
There will be 4 survey periods. Period 1 encompasses all survey modules administered from baseline up to week 8 (19 surveys/tasks per participant); period 2 from week 8 up to week 16 (18 surveys/tasks per participant); period 3 from week 16 up to week 24; period 4 from week 24 (16 surveys/tasks per participant).
详细描述
Participants in eFHS are invited to enroll from the FHS Offspring and Omni Group 1 Cohorts during the in-person examination 10/5 at the FHS Research Center in Framingham, Massachusetts (MA), USA or remotely from home after the in-person examination. All eFHS participants have the eFHS myDataHelps mobile app (developed by FHS investigators with CareEvolution our industry partner) installed on their smartphone. The eFHS app allows communication with participants through notifications and data collection. Participants are asked to answer health surveys administered through the app.
Survey assessments will include 6 modules: cognition, pain, mood, physical function and performance, physical activity, and events. The interventions are defined by the patterns of administration of survey modules to the experimental and control groups. The administration of the cognition, pain, mood, and psychosocial modules follow the same pattern for both groups. However, the administration of the physical function, physical activity, and events modules is delayed by 2 weeks in the experimental group as compared to the control 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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Invited to enroll from the FHS Offspring and Omni Group 1 Cohorts during the in-person examination 10/5 at the FHS Research Center
- •English speaking
- •English language reading proficiency
- •Owns an iPhone with compatible iOS (version 10.0 or higher) or Android (version 5.0 or higher)
- •Residence in the United States
- •Provision of permissions for notifications and data sharing with the Research Center
- •Provision of signed and dated informed consent (within the eFHS mobile app)
排除标准
- •Limited and non-readers
研究组 & 干预措施
Experimental Group
The experimental group will receive the physical function survey at weeks 2, 10, 18, and 26; the physical activity survey at weeks 2, 14, and 26; the events survey at weeks 2, 6, 10, 14, 18, 22, and 26. The administration of the cognition, pain, mood, and psychosocial surveys follow the same pattern for both groups.
干预措施: Delayed administration of survey modules (Other)
Control Group
The control group will receive the physical function survey at weeks 0, 8, 16, and 24; the physical activity survey at weeks 0, 12, and 24; the events survey at weeks 0, 4, 8, 12, 16, 20, and 24. The administration of the cognition, pain, mood, and psychosocial surveys follow the same pattern for both groups.
干预措施: Regular administration of survey modules (Other)
结局指标
主要结局
Proportion of Surveys/Tasks Returned in Period 4
时间窗: week 24, to completion of study usually 26 weeks
Proportion of surveys/task returned per participant (partially or fully completed) week 24, to completion of study usually 26 weeks, will be documented on the eFHS app.
Proportion of Surveys/Tasks Returned in Period 1
时间窗: baseline, up to week 8
Proportion of surveys/task returned per participant (partially or fully completed) from baseline, up to week 8, will be documented on the eFHS app.
Proportion of Surveys/Tasks Returned in Period 2
时间窗: week 8, up to week 16
Proportion of surveys/task returned per participant (partially or fully completed) from week 8, up to week 16, will be documented on the eFHS app.
Proportion of Surveys/Tasks Returned in Period 3
时间窗: week 16, up to week 24
Proportion of surveys/task returned per participant (partially or fully completed) week 16, up to week 24, will be documented on the eFHS app.
次要结局
- Proportion of Questions/Task Completed Per Participant in Period 3(week 16, up to week 24)
- Proportion of Questions/Task Completed Per Participant in Period 4(week 24, to completion of study usually 26 weeks)
- Proportion of Questions/Task Completed Per Participant in Period 2(week 8, up to week 16)
- Proportion of Questions/Task Completed Per Participant in Period 1(baseline, up to week 8)