跳至主要内容
临床试验/NCT03284203
NCT03284203终止不适用

Feasibility of Inpatient and At-Home Use of Handheld Spirometry (SpiroPD)

University of Chicago1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2017年9月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
8
试验地点
1
主要终点
Comparison of KOKO Spirometry to SpiroPD Use

研究概览

简要总结

The investigators' central hypotheses predict that the handheld spirometry device will be feasible for inpatient and at-home use, and is equally efficacious at determining lung function when compared to traditional, bedside spirometry measurements. To test these hypotheses, the investigators propose the following specific aims:

Specific Aim 1: Determine the correlation of SpiroPD handheld spirometry measurements with bedside Koko spirometry lung function.

Hypothesis: Correlation between the two lung function tests will be substantial for both hospitalized and ambulatory patients.

Specific Aim 2: To determine the feasibility, adherence, and preliminary management efficacy of home SpiroPD testing.

Hypotheses: (1) Patients will demonstrate substantial adherence to daily home spirometry testing; (2) medication adherence will increase significantly in patients who are adherent to daily home spirometry testing; (3) acute care utilization will decrease significant in adherent patients.

详细描述

Chronic Obstructive Pulmonary Disease (COPD) results in nearly 750,000 hospitalizations annually and is the third leading cause of "early" (within 30-day) hospital readmissions in the United States. Curbing preventable early readmissions for acute exacerbations of COPD (AECOPD) has become a national priority, as demonstrated by the Medicare Hospital Readmissions Reduction financial penalty program. One critical barrier in assessing readmission risk is the lack of an easily-measured 'vital sign' for COPD: accurate, timely measurements of lung function. Unlike other medical problems that have validated, easily-obtained measurements of organ function, COPD evaluation often defaults to patient report and physician evaluation without critical physiologic data. This lack of objective pulmonary function data during AECOPD in turn leads to critical errors in disease severity assessment. However, the required, repeated measurements by spirometry that can demonstrate responses to therapy can be time-consuming and expensive to perform in a laboratory, and both equipment and staffing infrastructure for bedside testing is cumbersome and often not prioritized. For these reasons, spirometry frequently is not done for patients with AECOPD.

To monitor patient responses to therapy and to assess risks based on objective measures, the investigators propose to the study the use of a portable, patient-driven device ("SpiroPD") that can be used in both in-patient and outpatient settings, and that reports (via the internet) values collected in real time. While the device has been used in the lung transplant community and for patients with cystic fibrosis, no studies have been done to validate its use in COPD. This protocol involves in-hospital patient training with the device followed by serial measurements at home in the first 30 days post hospital-discharge.

Demonstration in a pilot, single-center trial of the usefulness of real-time, repeated hand-held spirometry to provide objective measurements of lung function in AECOPD will have a substantial impact on both patient health outcomes and on health care utilization and will set the stage for appropriate next-step studies and NIH grant applications. It is unknown whether this specific technology will be acceptable in the target population, though previous research suggests that older patients may be more willing to use home monitoring technology. This multi-disciplinary research team includes providers from the Department of Medicine and the UCM COPD Readmissions Program team.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
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
否

入选标准

  • •18+ years
  • •Physician-diagnosed COPD
  • •Able to perform spirometry
  • •Access to wireless internet at home
  • •Visual acuity of at least 20/50 in one eye

排除标准

  • •Currently in ICU
  • •Physician declines to provide consent
  • •Patient unable to provide consent or declines to provide consent

研究组 & 干预措施

SpiroPD

Experimental

Participants in the intervention arm will be given a handheld spirometry device to take home and use daily for 30 consecutive days.

干预措施: SpiroPD (Device)

结局指标

主要结局

Comparison of KOKO Spirometry to SpiroPD Use

时间窗: 30 days from patient enrollment

Participants will use the handheld spirometry device every day for 30 days. After use, the device will store spirometry measurements for each patient each day and the data will be synced over wifi to each individual's associated online account. Daily measurements from the SpiroPD device will be collected over the course of 30 days. These measurements will then be compared against spirometry measurements collected using the bedside KoKo machine during baseline and 30-day follow-up visits.

次要结局

  • Adherence to Using the SpiroPD Device at Home on a Daily Basis(30 days from patient enrollment)
  • Feasibility of Patients to Use the SpiroPD Device at Home Consistently(30 days from patient enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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