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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Home-based Health Management of COPD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02999685
• Other study ID #: 14-009016
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: June 2019

Study information

• Verified date: January 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 99 Years

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Emphysema
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Rehabilitation

Intervention

Behavioral:
• Home-base Pulmonary Rehab with Health Coaching

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Minnesota HealthSolutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life: Chronic Respiratory Questionaire	To determine the effect of the proposed system on disease specific quality of life. The instrument has 2 summary scores, physical and emotional	8 weeks from the start of the intervention
Primary	Daily Physical Activity measured by Actigraph	To determine the effectiveness of the proposed system, on daily physical activity measured by triaxial accelerometers	8 weeks from the start of the intervention

External Links

•   Mayo Clinic Clinical Trials