Validation of Video Monitoring to Assess Compliance in Clinical Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Sensitivity of Detecting Non-Compliance
研究概览
简要总结
This study tests the feasibility of having study participants use webcams to participate in research studies. The study scientists hypothesize (1) that webcams will be an adequate method of detecting a participant's ability to perform a tasks for a clinical trial (e.g., swallowing a pill, eating food) and (2) that a majority of study participants would be willing to use a webcam to participate in a research study.
详细描述
In the first phase of this study, the study scientists will research and compare technologies that will be used in video monitoring via webcam. The study team will also develop a standardized protocol for using the webcam technology through hands-on testing (without the use of study participants).
In the second phase of this study, video monitoring via webcam will be tested. Specifically, the study scientists will see whether the video recordings can be used to assess compliance to clinical interventions. Study participants will be recruited from among Pennington Biomedical Research Center employees and assigned to be either evaluators or testers. Testers will act as if they were study participants in a clinical study who are supposed to adhere to an intervention such as swallowing a pill or consuming food. They will be video-recorded by webcam while performing these tasks. Evaluators will then try to detect how well the testers followed the instructions for the task through in-person observation and by watching video recordings. Data from these tests will then be used to see whether watching the video recordings is as effective as watching in-person.
In the third phase of this study, past, current, and potential study participants at Pennington Biomedical Research Center will be surveyed to determine their comfort with using webcams and their likeliness to opt to use webcams to participate in clinical studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pennington Biomedical Research Center employees and trainees
- •Age 18 years and older
排除标准
- •Any employees who directly report to and are directly employed by the study's principal investigator
结局指标
主要结局
Sensitivity of Detecting Non-Compliance
时间窗: 1 Month
The sensitivity (true positive rate, as a percentage of total non-compliant events) of observers charged with detecting non-compliance to a mock study intervention will be tested both via in-person monitoring and monitoring by webcam. The mock study interventions that will be monitored will include pill swallowing and eating. Non-compliance events will be chosen from a defined list of non-compliant behaviors (e.g., tampering with the pill, spitting food into a napkin and not eating it), and will be performed by mock study participants. The observers will record the number of non-compliant events they actually observe the mock study participants performing. This data will be analyzed as described here in order to determine the validity of monitoring non-compliance by webcam, in comparison to in-person monitoring.
次要结局
- Specificity and Inter-Rater Agreement of Detecting Non-Compliance(1 Month)
- Attitudes Towards Using Webcams To Participate in Clinical Interventions(1 year)
研究者
Courtney Peterson
Principal Investigator
Pennington Biomedical Research Center