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Inspiration Point-A Digital Pulmonary Rehabilitation Tool Management Interventions

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ClinicalTrials.gov Identifier: NCT03801330
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : December 1, 2020
Sponsor:
Collaborator:
Wake Forest University Health Sciences
Information provided by (Responsible Party):
Blue Marble Rehab Inc

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.

Condition or disease Intervention/treatment Phase
COPD Other: Usual Care Pulmonary Rehabilitation Program Other: Pulmonary Rehabilitation Software-Based Home Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Inspiration Point-A Digital Pulmonary Rehabilitation Tool for Use With Self- Management Interventions
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: Usual Care
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
Participants in the Usual Care Pulmonary Rehabilitation Program group will complete an 8 week clinic based Pulmonary Rehabilitation Program (usual care).

Experimental: Software Tool
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
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)




Primary Outcome Measures :
  1. 6 Minute Walk Test [ Time Frame: Change from baseline 6 Minute Walk Test score at 2 months ]
    Measures distance walked in 6 minutes


Secondary Outcome Measures :
  1. Lung function as assessed by spirometry (air volume) [ Time Frame: Change from baseline Spirometry score at 2 months ]
    Spirometry is the most common form of measurement of lung function. The test measures the amount (volume) of air that can be inhaled and exhaled. Spirometry generates pneumotachographs, which are charts that plot the volume of air coming in and out of the lungs from one inhalation and one exhalation.

  2. Lung function as assessed by spirometry (air speed) [ Time Frame: Change from baseline Spirometry score at 2 months ]
    Spirometry is the most common form of measurement of lung function. The test measures the speed (flow) of air that can be inhaled and exhaled. Spirometry generates pneumotachographs, which are charts that plot the flow of air coming in and out of the lungs from one inhalation and one exhalation.

  3. Hospital Anxiety and Depression Test [ Time Frame: Change from baseline Hospital Anxiety and Depression Test score at 2 months ]
    Self-report of anxiety and depression in the community and hospital settings Total Score Scale ranges 0-21, 0 is best

  4. Modified Medical Research Council Dyspnea Scale (mMRC) [ Time Frame: Change from baseline Modified Medical Research Council Dyspnea Scale (mMRC) score at 2 months ]
    Single question questionnaire describing shortness of breath. Total Score Range from 0-4, 0 is better.

  5. Medical Outcomes Scale VR-12 [ Time Frame: Change from baseline VR-12 score at 2 months ]

    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."


  6. St Georges Respiratory Questionnaire (SGRQ) [ Time Frame: Change from baseline St Georges Questionnaire score at 2 months ]

    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


  7. Lung Information Needs Questionnaire (LINQ) [ Time Frame: Change from baseline Lung Information Needs Questionnaire score at 2 months ]

    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.


  8. Software Usability Scale (SUS) [ Time Frame: Change from baseline Software Usability Scale (SUS)score at 2 months ]
    Measures usability and learnability of software tools. Total Score provides percentile score indicating usability/learnability. Range 0-100, Higher (100%) is better.

  9. Timed Up and Go Test (TUG) [ Time Frame: Change from baseline TUG score at 2 months ]
    Measures the time taken to stand up from a chair, walk 10 feet, turn around, and return to sitting.

  10. 30 Second Sit to Stand Test (30STST) [ Time Frame: Change from baseline 30STST score at 2 months ]
    Measures the number of times a participant can stand from a seated position in 30 seconds

  11. 4 Stage Balance Test (4SBT) [ Time Frame: Change in 4STBT score at 2 months ]
    Measures balance in 4 increasing more challenging positions



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • 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:

  • 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 angina and Class 2-4 of chronic heart failure.
  • 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.
  • Current and active cancer treatment.
  • 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 events/conditions presenting fall risk or requiring assist devices for ambulation will also be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801330


Contacts
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Contact: Sheryl M Flynn, PT PhD 6262966400 sheryl@bluemarblehealthco.com
Contact: William Pu, MPH 6262966295 williampu@bluemarblehealthco.com

Locations
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United States, North Carolina
Carolinas Healthcare System Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Jill Ohar, MD    336-713-8850    johar@wakehealth.edu   
Contact: Sharon Cornelison    336-713-8850    scorneli@wakehealth.edu   
Sponsors and Collaborators
Blue Marble Rehab Inc
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Sheryl Flynn, PT PhD Blue Marble Health
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Responsible Party: Blue Marble Rehab Inc
ClinicalTrials.gov Identifier: NCT03801330    
Other Study ID Numbers: HL137502
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: To be determined

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Blue Marble Rehab Inc:
pulmonary rehabilitation
digital
telehealth
software
electronic health
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes