Innovative Pulmonary Rehabilitation Telehealth Program for Improving COPD Patient Outcomes

March 4, 2021 updated by: University of Kansas Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline to Week 12
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.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

American Association for Respiratory Care

Investigators

  • Principal Investigator: Cheryl Skinner, RRT, CPFT, University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 15, 2018

Primary Completion (ACTUAL)

March 3, 2021

Study Completion (ACTUAL)

March 3, 2021

Study Registration Dates

First Submitted

March 29, 2018

First Submitted That Met QC Criteria

March 29, 2018

First Posted (ACTUAL)

April 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 5, 2021

Last Update Submitted That Met QC Criteria

March 4, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00141490

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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