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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Home-based Health Management of COPD Patients

Conditions
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Chronic Obstructive Pulmonary Disease, Emphysema, Pulmonary Rehabilitation

Intervention / Treatment
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* Behavioral: Home-base Pulmonary Rehab with Health Coaching


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Home-base Pulm Rehab w/ Health Coaching<br>The intervention group starts with 8 weeks of Home-base Pulmonary Rehab with Health Coaching, followed by 8 weeks of observation. | Behavioral: Home-base Pulmonary Rehab with Health Coaching<br> <br> |
| Active Comparator: Control/Wait<br>The Control/Wait group starts with 8 weeks of observation, followed by 8 weeks of intervention (Home-base Pulm Rehab w/ Health Coaching). | Behavioral: Home-base Pulmonary Rehab with Health Coaching<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |