COPDNCT03801330
Inspiration Point-A Digital Pulmonary Rehabilitation Tool Management Interventions
A study testing Pulmonary Rehabilitation Software-Based Home Program in people with COPD, run by Blue Marble Rehab Inc at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Pulmonary Rehabilitation Software-Based Home Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Nov 2020to 25 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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
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- 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 locations and contacts
4 sites in 1 country.
United States4 sites
Wake Forest Baptist Health
Charlotte, North Carolina, 28203
Cabin Creek Health Systems Inc
Dawes, West Virginia, 25054
Duke University Healthcare
Durham, North Carolina, 27705
New River Health Association
Scarbro, West Virginia, 25917
About this study
Official title: Inspiration Point-A Digital Pulmonary Rehabilitation Tool for Use With Self- Management Interventions
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.
Read the 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.
- Conditions
- COPD
- Being tested
- Usual Care Pulmonary Rehabilitation Program, Pulmonary Rehabilitation Software-Based Home Program
- Keywords
- pulmonary rehabilitation, digital, telehealth, software, electronic health
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Care Pulmonary Rehabilitation ProgramOther
Participants in the Usual Care Pulmonary Rehabilitation Program group will complete an 8 week clinic based Pulmonary Rehabilitation Program (usual care).
Pulmonary Rehabilitation Software-Based Home ProgramOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Pulmonary Rehabilitation Software-Based Home Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute Walk Test
Measures distance walked in 6 minutes
Measured: Change from baseline 6 Minute Walk Test score at 2 months
Secondary outcomes (14)
Modified Medical Research Council Dyspnea Scale (mMRC)
Single question questionnaire describing shortness of breath. Total Score Range from 0-4, 0 is better.
Measured: Change from baseline Modified Medical Research Council Dyspnea Scale (mMRC) score at 2 months
Medical Outcomes Scale VR-12
Survey of health status and quality of life
From (https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form/scoring.html) "Scoring the RAND 36-Item Health Survey is a two-step process. First, precoded numeric values are recoded per the scoring key given in Table 1. Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. Table 2 lists the items averaged together to create each scale. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Hence, scale scores represent the average for all items in the scale that the respondent answered."
Measured: Change from baseline VR-12 score at 2 months
St Georges Respiratory Questionnaire (SGRQ)
A self-administered disease-specific instrument designed to measure the impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. The questionnaire has 50 items Scores range from 0-100, with higher scores indicating more limitations
https://www.thoracic.org/members/assemblies/assemblies/srn/questionaires/sgrq.php
Measured: Change from baseline St Georges Questionnaire score at 2 months
Lung Information Needs Questionnaire (LINQ)
The questionnaire used to identify a person with COPD's need for information about their disease. The questionnaire measures the extent to which the patient needs more information, as perceived by the patient and clinician. It is scored to produce an overall score and 6 domain scores (Disease knowledge, medicines, self-management, exercise, diet, smoking).
The score is the sum of all 6 domains with a range from 0-25. High scores indicate high information needs, a lower score is better.
Measured: Change from baseline Lung Information Needs Questionnaire score at 2 months
Software Usability Scale (SUS)
Measures usability and learnability of software tools. Total Score provides percentile score indicating usability/learnability. Range 0-100, Higher (100%) is better.
Measured: Change from baseline Software Usability Scale (SUS)score at 2 months
Timed Up and Go Test (TUG)
Measures the time taken to stand up from a chair, walk 10 feet, turn around, and return to sitting.
Measured: Change from baseline TUG score at 2 months
30 Second Sit to Stand Test (30STST)
Measures the number of times a participant can stand from a seated position in 30 seconds
Measured: Change from baseline 30STST score at 2 months
4 Stage Balance Test (4SBT)
Measures balance in 4 increasing more challenging positions
Measured: Change in 4STBT score at 2 months
COPD Assessment Test (CAT)
An 8 item test which measures the effect of COPD on a patient's overall health. The items on this test measure a patient's cough, sputum, breathlessness, chest tightness, confidence, activity, sleep and energy levels
Measured: Change in CAT score at 2 months
Depression Screen (DS)
A 2 question survey which can be used to evaluate your risk of depression
Measured: Change in DS score at 2 months
Charlson Index (CCI)
The Charlson comorbidity index predicts the one-year mortality for a patient who may have a range of comorbid conditions, such as heart disease or cancer (a total of 22 conditions). This index is helpful to ensure the groups are equal for the study comparison and statistics.
Measured: Change in CCI score at 2 months
Fall Risk Questionnaire (FRQ)
The FRQ is comprised of 13 questions about a person's history of falls and potential fall risk.
Measured: Change in FRQ score at 2 months
Positive Affect and Well-Being Short Form (PROMIS)
This test is a health-related quality of life questionnaire.
Measured: Change in PROMIS score at 2 months
Single Item Literacy Screener (SILS)
The SILS is a single item survey which determines literacy and health literacy. It is a direct assessment of a patient's need for assistance in reading health materials.
Measured: Change in SILS score at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start1 Nov 2020
- Primary completion25 Apr 2023
- Study completion25 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blue Marble Rehab Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wake Forest University Health Sciences
- Responsible party
- Sponsor
- Investigators
- Sheryl Flynn, PT PhD, Principal investigator, Blue Marble Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801330
- Sponsor's protocol ID
- HL137502
- Status last verified
- Jun 2023
- First submitted
- 9 Aug 2017
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To be determined
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiration Point-A Digital Pulmonary Rehabilitation Tool for Use With Self- Management Interventions
- ClinicalTrials.gov ID
- NCT03801330
- Acronym / sponsor ID
- HL137502
- Conditions
- COPD
- Keywords
- pulmonary rehabilitation, digital, telehealth, software, electronic health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Blue Marble Rehab IncIndustry (pharma, biotech, devices)
- Collaborators
- Wake Forest University Health Sciences
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 11 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual Care Pulmonary Rehabilitation ProgramParticipants 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. |
| Software Tool | Experimental | Other: Pulmonary Rehabilitation Software-Based Home ProgramParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual Care Pulmonary Rehabilitation ProgramParticipants in the Usual Care Pulmonary Rehabilitation Program group will complete an 8 week clinic based Pulmonary Rehabilitation Program (usual care). | Other | Usual Care |
| Pulmonary Rehabilitation Software-Based Home ProgramParticipants in the Pulmonary Rehabilitation Software-Based Home Program group will complete an 8-week home-based Pulmonary Rehabilitation Program using a software app (software) | Other | Software Tool |
Primary outcome
6 Minute Walk Test
Time frame: Change from baseline 6 Minute Walk Test score at 2 months
Measures distance walked in 6 minutes
14 secondary outcomes
Modified Medical Research Council Dyspnea Scale (mMRC)
Time frame: Change from baseline Modified Medical Research Council Dyspnea Scale (mMRC) score at 2 months
Medical Outcomes Scale VR-12
Time frame: Change from baseline VR-12 score at 2 months
St Georges Respiratory Questionnaire (SGRQ)
Time frame: Change from baseline St Georges Questionnaire score at 2 months
Lung Information Needs Questionnaire (LINQ)
Time frame: Change from baseline Lung Information Needs Questionnaire score at 2 months
Software Usability Scale (SUS)
Time frame: Change from baseline Software Usability Scale (SUS)score at 2 months
Timed Up and Go Test (TUG)
Time frame: Change from baseline TUG score at 2 months
30 Second Sit to Stand Test (30STST)
Time frame: Change from baseline 30STST score at 2 months
4 Stage Balance Test (4SBT)
Time frame: Change in 4STBT score at 2 months
COPD Assessment Test (CAT)
Time frame: Change in CAT score at 2 months
Depression Screen (DS)
Time frame: Change in DS score at 2 months
Charlson Index (CCI)
Time frame: Change in CCI score at 2 months
Fall Risk Questionnaire (FRQ)
Time frame: Change in FRQ score at 2 months
Positive Affect and Well-Being Short Form (PROMIS)
Time frame: Change in PROMIS score at 2 months
Single Item Literacy Screener (SILS)
Time frame: Change in SILS score at 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Individual participant dataSharing planned: No. To be determined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheryl Flynn, PT PhD principal investigator
Blue Marble Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Rehabilitation Software-Based Home Program in people with COPD, run by Blue Marble Rehab Inc at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minute Walk Test (time frame: Change from baseline 6 Minute Walk Test score at 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.