NCT03489642

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 29, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 5, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2021

Completed
Last Updated

March 5, 2021

Status Verified

March 1, 2021

Enrollment Period

3 years

First QC Date

March 29, 2018

Last Update Submit

March 4, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Quality of Life

    Change from Baseline to Week 12

  • Adherence to physical activity requirements

    Week 12

Study Arms (1)

COPD Telehealth Program

EXPERIMENTAL

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

Interventions

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

COPD Telehealth Program

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

  • Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Cheryl Skinner, RRT, CPFT

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR
  • Dave Burnett, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2018

First Posted

April 5, 2018

Study Start

February 15, 2018

Primary Completion

March 3, 2021

Study Completion

March 3, 2021

Last Updated

March 5, 2021

Record last verified: 2021-03

Locations