Innovative Pulmonary Rehabilitation Telehealth Program for Improving COPD Patient Outcomes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03489642|
Recruitment Status : Recruiting
First Posted : April 5, 2018
Last Update Posted : November 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|COPD||Behavioral: Telehealth Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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|
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.
- 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.
- 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.
- 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.
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
|Contact: Cheryl Skinner, RRT, CPFT||(913) firstname.lastname@example.org|
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Cheryl Skinner, RRT, CPFT||University of Kansas Medical Center|
|Principal Investigator:||Dave Burnett, PhD||University of Kansas Medical Center|