Evaluation of COPD Co-Pilot

HGE Health Care Solutions, LLC1 个研究点分布在 1 个国家目标入组 23 人2017年1月

适应症COPD

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: COPD
发起方: HGE Health Care Solutions, LLC
入组人数: 23
试验地点: 1
主要终点: Patient Adoption
最后更新: 8年前

概览研究者入排标准结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2017年1月

结束日期

2018年3月

最后更新

8年前

研究类型

Observational

性别

All

研究者

发起方

HGE Health Care Solutions, LLC

责任方

Sponsor

入排标准

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

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)
Episode duration(6 months)
Patient profile information(6 months)
Source of inpatient admissions and visits to the Emergency Department (ED)(6 months)
Inpatient Admissions(6 months)
Hospitalization history(6 months)
Readmission rate(6 months)
Length of stay(6 months)
Readmissions(6 months)