NCT03801330已完成不适用
Inspiration Point-A Digital Pulmonary Rehabilitation Tool for Use With Self- Management Interventions
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 8
- 主要终点
- 6 Minute Walk Test
研究概览
简要总结
The purpose of this study is to measure the feasibility of use of a digital pulmonary rehabilitation tool compared with standard care home program pulmonary rehabilitation.
详细描述
The study design is a between subjects (Usual care/App) repeated measures (pre/post) design to compare the feasibility of usual care compared with the digital app, Inspiration Point, used in the home for 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Participants will have physician permission and diagnosis COPD (FEV1 >30%-80%),
- •Gold level A-D, and
- •Ability to perform the 6 Minute Walk Test (6MWT).
- •This means that participants must meet the standard definition of COPD and have a post-bronchodilator measurement of FEV1/FVC < 0.
- •All COPD Assessment Test scores will be accepted.
- •Patients must have an mMRC score = 1-
- •Additionally, patients must have taken a Pulmonary Function Test within 1 year or they must retake (for baseline measurement) before participating in the study.
- •Patients must not have had a Pulmonary Rehabilitation class within the last 6 months.
- •If participants have had a recent cardiac event within 6 months (such as a myocardial infarction or an abnormal cardiac catheterization) they must obtain cardiologist approval before participating in the study.
- •In an effort to evaluate feasibility we will request that participants have their own Wi-Fi. Participants may use their own mobile device if they prefer but Blue Marble will have ample supply to provide to participants a device for the purposes of this study.
- •Target representativeness for gender, based on COPD demography will be ~50% women, based on recent trends indicating that women have an equal, and perhaps slightly greater risk of COPD compared to men
- •The Ethnicity/Race target recruitment, consistent with the US and the population at each site.
- •Participants must speak, read, and understand English at or above the 6th-grade level (as indicated by having a driver's license or self-report of completion of some high school).
- •Exclusion Criteria for participants with COPD:
- •Pulmonary functional fitness that precludes participation in outpatient/home PR program (i.e. requires in-patient supervision or severity of a co-morbidity that represents a contradiction to exercise in a self-directed program) will be exclusionary.
- •A participant who desaturates below SaO2 <88% during the pre-test 6MWT and does not have personal oxygen available will be referred for further evaluation and can be included once they have an O2 titration and supplemental oxygen.
- •Other exclusions include if a patient's oxygen use exceeds 4 liters per minute (LPM) or those who score less than 100 meters during the entry 6-minute walk distance.
- •Participants with coronary problems will be excluded based on specific morbidity and severity. These coronary exclusions include coronary artery disease with unstable angina.
- •Additional exclusions include: any respiratory disorder other than COPD that contraindicates participation in a home-based program.
- •The inability to learn how to use Inspiration Point
- •An acute neurological or cardiovascular condition such as stroke or acute heart surgery.
- •Active cancer with an anticipated survival of less than 6 months or treatment that will preclude them from participating in Pulmonary Rehab.
- •A participant with high fall risk as per physician determination.
- •The presence of a neurologic disorder that precludes a potential participant from following a typical COPD exercise program or demonstrating hand function sufficient to interface with the tablet.
- •This also includes patients with prior or current neurologic event/condition presenting fall risk or requiring assist device for ambulation will also be excluded.
排除标准
- 未提供
结局指标
主要结局
6 Minute Walk Test
时间窗: Change from baseline 6 Minute Walk Test score at 2 months
Measures distance walked in 6 minutes
次要结局
- Modified Medical Research Council Dyspnea Scale (mMRC)(Change from baseline Modified Medical Research Council Dyspnea Scale (mMRC) score at 2 months)
- COPD Assessment Test (CAT)(Change in CAT score at 2 months)
- Medical Outcomes Scale VR-12(Change from baseline VR-12 score at 2 months)
- Software Usability Scale (SUS)(Change from baseline Software Usability Scale (SUS)score at 2 months)
- Depression Screen (DS)(Change in DS score at 2 months)
- St Georges Respiratory Questionnaire (SGRQ)(Change from baseline St Georges Questionnaire score at 2 months)
- Fall Risk Questionnaire (FRQ)(Change in FRQ score at 2 months)
- Positive Affect and Well-Being Short Form (PROMIS)(Change in PROMIS score at 2 months)
- Single Item Literacy Screener (SILS)(Change in SILS score at 2 months)
- Lung Information Needs Questionnaire (LINQ)(Change from baseline Lung Information Needs Questionnaire score at 2 months)
- Timed Up and Go Test (TUG)(Change from baseline TUG score at 2 months)
- 30 Second Sit to Stand Test (30STST)(Change from baseline 30STST score at 2 months)
- 4 Stage Balance Test (4SBT)(Change in 4STBT score at 2 months)
- Charlson Index (CCI)(Change in CCI score at 2 months)
研究者
研究点 (8)
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