A Home-based Module to Promote Mindful Breathing Awareness for COPD Patients

Study Overview
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Brief Summary
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The purpose of this study is to develop a mindful breathing module to an already effective and developed home based rehabilitation program for guiding COPD patients in a mindful breathing practice and further palliate breathlessness and anxiety.

Detailed Description
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A breathing technique called Pursed Lipped Breathing (PLB) has been proven to be beneficial for patients with COPD. PLB can ease shortness of breath and reduce stress and anxiety. This study will develop a mindful PLB module to compliment an already developed home based pulmonary rehabilitation program. In this study, patients will be randomized to either a group that does the home based pulmonary rehabilitation with the mindful breathing module and health coaching or a group that does the home based pulmonary rehabilitation with health coaching without the mindful breathing module. Both groups will do the home based pulmonary rehabilitation for 12 weeks. In addition there are questionnaires and the wearing of an activity monitor when you sign up and at 3 and 6 months.

Official Title
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A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients

Conditions
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COPD

Intervention / Treatment
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* Behavioral: Home-based pulmonary rehabilitation program
* Behavioral: Mindful breathing module
* Behavioral: Health coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults, age ≥ 40 years old. Clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD). At least 10 pack years of smoking. Exclusion Criteria: Unable to do mild exercise (orthopedic-neurologic problems or confined to a bed). Unable to follow commands (cognitive impairment). Have a high likelihood of being lost to follow-up (active alcohol or drug abuse). Live in an area that does not have cellular service (Verizon).

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-base pulmonary rehabilitation with mindful breathing modu<br>Subjects will complete in a home-based pulmonary rehabilitation program and in addition will complete a mindful breathing practice using a module on a computer tablet. | Behavioral: Home-based pulmonary rehabilitation program<br>* Subjects will wear an activity monitor while doing at home exercises using a computer tablet<br>Behavioral: Mindful breathing module<br>* Additional module on the computer tablet that involves inhaling and exhaling while following an animated ball on the computer screen.<br>Behavioral: Health coaching<br>* Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing<br>|
| Active Comparator: Home-base pulmonary rehabilitation<br>Subjects will complete 12 week home-based pulmonary rehabilitation with health coaching | Behavioral: Home-based pulmonary rehabilitation program<br>* Subjects will wear an activity monitor while doing at home exercises using a computer tablet<br>Behavioral: Health coaching<br>* Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Chronic Respiratory Disease Questionnaire (CRQ)- Dyspnea Summary | The CRQ is a 20-question inventory assessing the areas of health related quality of life in dyspnea (shortness of breath), fatigue, emotion, and feelings of mastery of chronic respiratory disease. The Dyspnea Summary score includes dyspnea (symptom #1 in COPD) and fatigue (symptom #2 in COPD) domains. The questions in each domain are added together and then divided by the number of questions. The possible range is 1-7, where 1 is the worst and 7 the best. | The change from baseline of the CRQ will be assessed at 3 and 6 month. | 
| Change in Chronic Respiratory Disease Questionnaire (CRQ)- Emotions Summary | The CRQ Emotion Summary score includes the emotion (independent factor for admissions and poor quality of life) and mastery (self-management) domains of the CRQ. The scores for each domain are calculated by simply added together the answers and then dividing by the number of questions, the range is 1-7 where 1 is the worst and 7 the best. | The change from baseline of the CRQ will be assessed at 3 and 6 month. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in daily Physical Activity- daily steps | An Actigraph activity monitor will be used to measure daily steps and activity counts. The activity monitor is wrist worn for 7 days. | The change from baseline on daily Physical activity will be assessed at 3 and 6 month. |