NCT03879291终止不适用
Assessment of Utility of accelerateIQ in the Care of Patients Participating in a Pulmonary Rehabilitation Program
Karen Larimer1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2019年1月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Clinical Utility
研究概览
简要总结
The proposed study seeks to assess the performance of continuous biosensor data and machine learning analytics in assessment of health patient status in a pulmonary rehabilitation program.
It is hypothesized that using continuous physiologic biosensor data and machine learning analytics to detect changes in physiology may play a role in managing patients in the pulmonary rehabilitation setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, at least 40 years of age;
- •Diagnosis of Chronic Obstructive Pulmonary Disease (COPD);
- •Enrolled in the study site's 12-week pulmonary rehabilitation program;
- •Capable of completing a 6-minute walk test;
- •Willing and able to comply with scheduled protocol procedures and follow up;
- •Signed and dated informed consent and HIPAA materials indicating that the patient has agreed to participate in this study and has been informed of all pertinent aspects of the trial.
排除标准
- •Patient has cognitive or physical limitations that, in the opinion of the investigator, limit the patient's ability to utilize the System as instructed;
- •Patient is actively enrolled in another clinical investigation that, in the opinion of the investigator, interferes with or compromises either that patient's ability to participation in this study or the ability for the study to generate results;
- •Patients who have implanted defibrillators or pacemakers;
- •Patient is allergic to hydrocolloid adhesive;
- •Patient does not speak English.
结局指标
主要结局
Clinical Utility
时间窗: 90 days
Correlation of reported health events with the multivariate change index
次要结局
未报告次要终点
研究者
Karen Larimer
Director of Clinical Development
physIQ, Inc.
研究点 (1)
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