Inspiration Point-A Digital Pulmonary Rehabilitation Tool Management Interventions

Blue Marble Health

Status: Completed

Conditions: COPD

Treatments: Other: Pulmonary Rehabilitation Software-Based Home Program; Other: Usual Care Pulmonary Rehabilitation Program

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03801330

HL137502

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Usual Care

Active Comparator group

Description:

Participants in the Usual Care Pulmonary Rehabilitation will receive usual care pulmonary rehab program. Usual care programs typically consist of exercises including upper extremity strengthening, lower extremity strengthening, aerobic exercises such as walking and balance training. Each program is personalized as per the participant's ability. The intervention is usual care exercise and education, which is personalized for each participant. No drugs are being tested in this study.

Treatment:

Other: Usual Care Pulmonary Rehabilitation Program

Software Tool

Experimental group

Description:

Participants in the Pulmonary Rehabilitation Software-Based Home Program will use a digital software tool (APP) to obtain the pulmonary rehab home program. Home programs typically consist of exercises including upper extremity strengthening, lower extremity strengthening, aerobic exercises such as walking and balance training. Each program is personalized as per the participant's ability. The intervention is exercise and education, which is personalized for each participant. No drugs are being tested in this study.

Treatment:

Other: Pulmonary Rehabilitation Software-Based Home Program