NCT03018847Unknown不适用
Evaluation of COPD Co-Pilot
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Patient Adoption
研究概览
简要总结
The purpose of undertaking this study is to examine the use of COPD Co-PilotTM, a COPD disease management program manufactured and operated by HGE Health Care Solutions, LLC, in COPD patients outside of the geographic base of HGE's existing patient population (Philadelphia, PA). The purpose is to demonstrate the feasibility of expanding the program to additional geographic sites and to examine whether similar outcome measures are achieved in patients under the supervision of health care providers that are new to the program.
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研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has read, understood and signed an informed consent form prior to enrollment.
- •Males or females age ≥35 years old
- •Documented diagnosis of moderate to very severe COPD (GOLD Level II-IV)
- •Must be able to read and understand English and consent for themselves
- •Subject is willing and able to use an iPad mini device.
排除标准
- •Subject has a cognitive impairment (determined by physician) that will make it hard to follow instructions regarding device usage
- •Subject is currently known to suffer from or have a history of significant substance abuse within the last 2 years
- •Subject has any condition that in the opinion of the provider may adversely affect their participation
- •Subject is residing in hospice care, Skilled Nursing Facilities or Long Term Acute Care facilities
- •Subject has a planned procedures at time of enrollment that will occur within timeframe of study that will require hospitalization or otherwise adversely affect their ability to participate
- •Subject has no cellular coverage at their primary residence
- •Subject plans to travel to a location with no cellular coverage for a significant period (>1 week) during their program participation
结局指标
主要结局
Patient Adoption
时间窗: 6 months
Percentage of potential daily symptom reports completed by patients
次要结局
- Readmission rate(6 months)
- Patient Satisfaction(6 months)
- Symptom change detected(6 months)
- Clinical responses(6 months)
- Medication compliance(6 months)
- Emergency department visits(6 months)
- Clinic visits(6 months)
- Medications(6 months)
- Patient reported respiratory symptoms(6 months)
- Patient profile information(6 months)
- Source of inpatient admissions and visits to the Emergency Department (ED)(6 months)
- Inpatient Admissions(6 months)
- Episode duration(6 months)
- Hospitalization history(6 months)
- Length of stay(6 months)
- Readmissions(6 months)
研究者
研究点 (1)
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