Innovative Pulmonary Rehabilitation Telehealth Program for Improving COPD Patient Outcomes

COPD Clinical Trial

Official title:

Innovative Pulmonary Rehabilitation Telehealth Program for Improving COPD Patient Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03489642
• Other study ID #: STUDY00141490
• Status: Completed
• Phase: N/A
• Start date: February 15, 2018
• Est. completion date: March 3, 2021

Study information

• Verified date: March 2021
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 3, 2021
• Est. primary completion date: March 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

Behavioral:
• Telehealth Program
Telehealth program delivered remotely to study participants. Program developed by Cambium Technologies.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	American Association for Respiratory Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of physical activity	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.	Change from Baseline to Week 12
Secondary	Quality of Life	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.	Change from Baseline to Week 12
Secondary	Adherence to physical activity requirements	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.	Week 12