Clinical trial NCT03801330: Inspiration Point-A Digital Pulmonary Rehabilitation Tool Management Interventions
Official title: Inspiration Point-A Digital Pulmonary Rehabilitation Tool for Use With Self- Management Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: pulmonary rehabilitation
digital
telehealth
software
electronic health
Lead sponsor: Blue Marble Rehab Inc
Sponsor class: INDUSTRY
Collaborators: name: Wake Forest University Health Sciences
First posted: 2019-01-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 for 8 weeks.

Eligibility 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.

Primary outcomes:
measure: 6 Minute Walk Test
timeFrame: Change from baseline 6 Minute Walk Test score at 2 months
Secondary outcomes:
measure: Modified Medical Research Council Dyspnea Scale (mMRC)
timeFrame: Change from baseline Modified Medical Research Council Dyspnea Scale (mMRC) score at 2 months
measure: Medical Outcomes Scale VR-12
timeFrame: Change from baseline VR-12 score at 2 months
measure: St Georges Respiratory Questionnaire (SGRQ)
timeFrame: Change from baseline St Georges Questionnaire score at 2 months
measure: Lung Information Needs Questionnaire (LINQ)
timeFrame: Change from baseline Lung Information Needs Questionnaire score at 2 months
measure: Software Usability Scale (SUS)
timeFrame: Change from baseline Software Usability Scale (SUS)score at 2 months
measure: Timed Up and Go Test (TUG)
timeFrame: Change from baseline TUG score at 2 months
measure: 30 Second Sit to Stand Test (30STST)
timeFrame: Change from baseline 30STST score at 2 months
measure: 4 Stage Balance Test (4SBT)
timeFrame: Change in 4STBT score at 2 months
measure: COPD Assessment Test (CAT)
timeFrame: Change in CAT score at 2 months
measure: Depression Screen (DS)
timeFrame: Change in DS score at 2 months
measure: Charlson Index (CCI)
timeFrame: Change in CCI score at 2 months
measure: Fall Risk Questionnaire (FRQ)
timeFrame: Change in FRQ score at 2 months
measure: Positive Affect and Well-Being Short Form (PROMIS)
timeFrame: Change in PROMIS score at 2 months
measure: Single Item Literacy Screener (SILS)
timeFrame: Change in SILS score at 2 months
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Durham
country: United States
facility: Duke University Healthcare
state: North Carolina
city: Dawes
country: United States
facility: Cabin Creek Health Systems Inc
state: West Virginia
city: Scarbro
country: United States
facility: New River Health Association
state: West Virginia
Study officials:
affiliation: Blue Marble Health
name: Sheryl Flynn, PT PhD
role: PRINCIPAL_INVESTIGATOR
References: