Inspiration Point-A Digital Pulmonary Rehabilitation Tool Management Interventions

Completed · Not applicable

Conditions studied: COPD

In brief

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.

Key facts

Study ID

NCT03801330

Run by

Blue Marble Rehab Inc

People needed

48

Starts

2020-11-01

Expected to finish

2023-04-25

Last updated by the study team

2023-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 < 0.7.
• All COPD Assessment Test scores will be accepted.
• Patients must have an mMRC score = 1-4.
• 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 men3.
• 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.

Where it is running

• Wake Forest Baptist Health — Charlotte, North Carolina, United States
• Duke University Healthcare — Durham, North Carolina, United States
• Cabin Creek Health Systems Inc — Dawes, West Virginia, United States
• New River Health Association — Scarbro, West Virginia, United States

Full record on ClinicalTrials.gov

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