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Inspiration Point-A Digital Pulmonary Rehabilitation Tool Management Interventions

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ClinicalTrials.gov Identifier: NCT03801330
Recruitment Status : Not yet recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Collaborators:
Carolinas Healthcare System
Fusion Health
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: Pulmonary Rehabilitation Paper-Based Home 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: 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
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: Usual Care
Participants in the Pulmonary Rehabilitation Paper-Based Home Program will receive usual care pulmonary rehab home programs (paper handout). 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 Paper-Based Home Program
Participants in the Pulmonary Rehabilitation Paper-Based Home Program group will complete a Pulmonary Rehabilitation Home Program using a paper-based exercise program for two months (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 a Pulmonary Rehabilitation Home Program using a software app for two months (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. Pulse Oximetry to measure oxygen saturation [ Time Frame: Change from baseline Pulse Oximetry to measure oxygen saturation score at 2 months ]
    A non-invasive photo-electric measure of blood oxygen saturation

  4. 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

  5. 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.

  6. Medical Outcomes Scale SF-36 [ Time Frame: Change from baseline Medical Outcomes Scale SF-36 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."


  7. 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


  8. Lung Information Needs Questionnaire [ 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.


  9. 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.



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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 a self-reported COPD diagnosis of GOLD Stage 1 or 2.

Exclusion Criteria:

  • Participants must be able to stand for at least 10 min and walk independently with or without support (cane, chair, walker).
  • Participants must be able to transport themselves or have caregivers that will transport them to the facility for testing.
  • Participants must speak, read, and understand English at or above the 8th-grade level (as indicated by having a driver's license or self-report of completion of high school).
  • Participants will also be required to have Wi-Fi.

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
Contact: Sheryl M Flynn, PT PhD 6262966400 sheryl@bluemarblehealthco.com
Contact: Vanessa Oviedo, BS 6262966295 vanessa@bluemarblehealthco.com

Locations
United States, Florida
Fusion Health Not yet recruiting
Oakland Park, Florida, United States, 33334
Contact: Keith Robinson    954-900-5635    kejaro2000@yahoo.com   
United States, North Carolina
Carolinas Healthcare System Not yet recruiting
Charlotte, North Carolina, United States, 28203
Contact: Myra Stearns    704-667-0250    myra.stearns@carolinashealthcare.org   
Contact: Traci Grindo    7043552046    traci.grindo@carolinashealthcare.org   
Sponsors and Collaborators
Blue Marble Rehab Inc
Carolinas Healthcare System
Fusion Health
Investigators
Principal Investigator: Sheryl Flynn, PT PhD Blue Marble Health

Responsible Party: Blue Marble Rehab Inc
ClinicalTrials.gov Identifier: NCT03801330     History of Changes
Other Study ID Numbers: HL137502
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: To be determined

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:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes