Home-Based Health Management of COPD Patients

Study Overview
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Brief Summary
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Minnesota HealthSolutions Corporation (MHS) proposes to develop and evaluate a program to motivate and monitor people with chronic obstructive pulmonary disease (COPD) to complete home exercise as part of pulmonary rehabilitation (PR). The proposed system has two components: home-based activity monitoring and health coaching. The investigators will conduct a randomized, wait-list controlled clinical study to evaluate the effects of the activity monitoring system and health coaching on quality of life and daily steps.

Official Title
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Home-Based Health Management of COPD Patients

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Behavioral: health coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of GOLD stage II, III, or IV COPD current or previous smoker with at least 10 pack-years of cigarette smoking be hospitalized for an exacerbation of COPD Exclusion Criteria: high likelihood of being lost to follow-up or contact inability to provide good data or follow commands inability to do mild exercise

Ages Eligible for Study
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Minimum Age: 40 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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Activity Monitor plus Health Coaching<br>Device: Actigraph Participants will wear the device daily during weeks 1, 9, and 17. Daily steps and activity will be measured. It will identify if they complete a prescribed exercise regimen. Participants in the intervention condition (wearing the Actigraph) will also receive supportive health coaching to encourage them to exercise. | Behavioral: health coaching<br>* Supportive coaching to encourage compliance with prescribed pulmonary rehabilitation.<br>|
| No Intervention: Control<br>Device: Actigraph Participants will wear the device daily during weeks 1, 9, and 17. Daily steps and activity will be measured. It will identify if they complete a prescribed exercise regimen. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Number of Daily Steps Between the Intervention and Control Conditions | Number of daily steps as measured by the SenseWear Pro ArmBand, which is an accepted criterion measure for daily physical activity in adults with Chronic Obstructive Pulmonary Disease. | Steps measured at baseline (week 1) and week 9 | 
| Change in Physical Quality of Life Between the Intervention and Control Conditions | Measure Description: The Chronic Respiratory Disease Questionnaire measures physical and emotional aspects with 20 items in four domains/categories. The two domains/categories used for physical summary were dyspnea and fatigue. The items are assessed numerically on a 7-point modified Likert scale (from 1 to 7). Scores are obtained by adding the scores for the items that make up each category and dividing by the number of items. Physical quality of life is obtained by adding the fatigue and dyspnea scores and dividing by two; hence, the score range is from 1 to 7. Higher scores indicate better health-related quality of life. Scores are obtained by adding the scores for the items that make up each category and dividing by the number of items. A minimally important difference is a change in score of 0.5 or more. | Quality of Life measured at baseline (week 1) and week 9 |