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Innovative Pulmonary Rehabilitation Telehealth Program for Improving COPD Patient Outcomes

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ClinicalTrials.gov Identifier: NCT03489642
Recruitment Status : Recruiting
First Posted : April 5, 2018
Last Update Posted : November 7, 2019
Sponsor:
Collaborator:
American Association for Respiratory Care
Information provided by (Responsible Party):
University of Kansas Medical Center

Brief Summary:
Researchers want to learn more about telehealth pulmonary rehabilitation programs that help people with Chronic obstructive pulmonary disease (COPD) improve physical activity and quality of life.

Condition or disease Intervention/treatment Phase
COPD Behavioral: Telehealth Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Innovative Pulmonary Rehabilitation Telehealth Program for Improving COPD Patient Outcomes
Actual Study Start Date : February 15, 2018
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: COPD Telehealth Program
Participants will take part in a structured telehealth program for 12 weeks. Web-based educational tools will be made available to participants. Study participants will meet with a registered respiratory therapist two times per week.
Behavioral: Telehealth Program
Telehealth program delivered remotely to study participants. Program developed by Cambium Technologies.




Primary Outcome Measures :
  1. Measure of physical activity [ Time Frame: Change from Baseline to Week 12 ]
    Changes will be measured using the Yale Physical Activity Survey (YPAS). The tool is composed of two sections - (a) amount of physical activity/exercise performed during a typical week in the past month and (b) activities performed in the past month. The final index score is the sum of five individual indices (vigorous, leisurely walking, moving, standing and sitting). Scores on the scale range from 0 to 137. The higher the score the more active a person.


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: Change from Baseline to Week 12 ]
    The COPD Assessment Test (CAT) will be used to measure the health status of the subjects. The test has eight questions. Each question has a range from 0-5. The total score for the test ranges from 0 to 40. The higher the score the more severe a person's COPD.

  2. Adherence to physical activity requirements [ Time Frame: Week 12 ]
    Patients receive an individualized exercise plan (minutes and days per week). Adherence to physical activity is assessed by the proportion of weeks subjects achieve their planned physical activity time.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hospital discharge diagnosis of COPD
  • Spirometry-confirmed evidence of COPD Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages I to IV
  • Access to internet connection and knowledge on use of web-based programs

Exclusion Criteria:

  • Persons with additional significant comorbidities including cancer, cardiac disease and physical impairments
  • Non-English speaking persons
  • The inability to provide an informed consent

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): NCT03489642


Contacts
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Contact: Cheryl Skinner, RRT, CPFT (913) 588-4634 cskinner@kumc.edu

Locations
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United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
American Association for Respiratory Care
Investigators
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Principal Investigator: Cheryl Skinner, RRT, CPFT University of Kansas Medical Center
Principal Investigator: Dave Burnett, PhD University of Kansas Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03489642    
Other Study ID Numbers: STUDY00141490
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No