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OpenTrials
Completed

NCT Number: NCT02999685

Home-based Health Management of Chronic Obstructive Lung Disease (COPD) Patients

Regular physical activity has been found to be important in maintaining health and well-being in people with COPD. The purpose of this study is to test new technology and health coaching aimed to help people with COPD become more physically active in their daily lives.

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Key information

Age range

40 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55902, United States

About this study

This study consists of a home-based pulmonary rehabilitation system. The system consists of a tablet computer, pulse oximeter, activity monitor and weekly telephone health coach calls. The rehabilitation period lasts 8 weeks. This is a randomized trial with two groups. Group A will complete the study activities during the first 8 weeks of the study followed by a period of observation. Group B will complete 8 weeks of observation followed by 8 weeks of rehabilitation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Men and women age 40 years and older
  • Current or former smoker of at least 10 pack-years
  • Diagnosis of Global Initiative for Chronic Lung Disease (GOLD) stage II, III or IV COPD as documented by pulmonary function
  • Are eligible for Pulmonary Rehabilitation

Exclusion criteria

  • • Unable to perform mild exercises
  • Patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move out of the state, are not living in the healthcare area.
  • Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).

Treatment and study plan

Home-base Pulmonary Rehab with Health Coaching

Behavioral

Primary outcomes

  1. Quality of Life: Chronic Respiratory Questionaire

    Time frame: 8 weeks from the start of the intervention

    To determine the effect of the proposed system on disease specific quality of life. The instrument has 2 summary scores, physical and emotional

  2. Daily Physical Activity measured by Actigraph

    Time frame: 8 weeks from the start of the intervention

    To determine the effectiveness of the proposed system, on daily physical activity measured by triaxial accelerometers

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Minnesota HealthSolutions

Registry information

Official study title

Home-based Health Management of COPD Patients

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 21, 2016
Registry last updated
Jan 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.