Inspiration Point-A Digital Pulmonary Rehabilitation Tool Management Interventions

NCT03801330 | Completed

• 1 other identifier: HL137502
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 4

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.

Conditions

COPD

Keywords

pulmonary rehabilitation; digital; telehealth; software; electronic health

Outcome Measures

Primary Outcomes (1)

• 6 Minute Walk Test

  Measures distance walked in 6 minutes

  Change from baseline 6 Minute Walk Test score at 2 months

Secondary Outcomes (14)

• Modified Medical Research Council Dyspnea Scale (mMRC)

  Change from baseline Modified Medical Research Council Dyspnea Scale (mMRC) score at 2 months

• Medical Outcomes Scale VR-12

  Change from baseline VR-12 score at 2 months

• St Georges Respiratory Questionnaire (SGRQ)

  Change from baseline St Georges Questionnaire score at 2 months

• Lung Information Needs Questionnaire (LINQ)

  Change from baseline Lung Information Needs Questionnaire score at 2 months

• Software Usability Scale (SUS)

  Change from baseline Software Usability Scale (SUS)score at 2 months

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

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.

Other: Usual Care Pulmonary Rehabilitation Program

Software Tool

EXPERIMENTAL

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.

Other: Pulmonary Rehabilitation Software-Based Home Program

Interventions

Usual Care Pulmonary Rehabilitation Program OTHER

Participants in the Usual Care Pulmonary Rehabilitation Program group will complete an 8 week clinic based Pulmonary Rehabilitation Program (usual care).

Usual Care

Pulmonary Rehabilitation Software-Based Home Program OTHER

Participants in the Pulmonary Rehabilitation Software-Based Home Program group will complete an 8-week home-based Pulmonary Rehabilitation Program using a software app (software)

Software Tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Blue Marble Rehab Inc: lead
• Wake Forest University Health Sciences: collaborator

Study Sites (4)

Wake Forest Baptist Health

Charlotte, North Carolina, 28203, United States

Location

Duke University Healthcare

Durham, North Carolina, 27705, United States

Location

Cabin Creek Health Systems Inc

Dawes, West Virginia, 25054, United States

Location

New River Health Association

Scarbro, West Virginia, 25917, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sheryl Flynn, PT PhD

  Blue Marble Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: January 11, 2019
• Study Start: November 1, 2020
• Primary Completion: April 25, 2023
• Study Completion: April 25, 2023
• Last Updated: June 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)