Status:
COMPLETED
Inspiration Point-A Digital Pulmonary Rehabilitation Tool Management Interventions
Lead Sponsor:
Blue Marble Rehab Inc
Collaborating Sponsors:
Wake Forest University Health Sciences
Conditions:
COPD
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2023
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03801330
Start Date
November 1 2020
End Date
April 25 2023
Last Update
June 9 2023
Active Locations (4)
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1
Wake Forest Baptist Health
Charlotte, North Carolina, United States, 28203
2
Duke University Healthcare
Durham, North Carolina, United States, 27705
3
Cabin Creek Health Systems Inc
Dawes, West Virginia, United States, 25054
4
New River Health Association
Scarbro, West Virginia, United States, 25917