Mechanistic Effects of Health Coaching to Reduce COPD Hospitalizations

Study Overview
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Brief Summary
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This pilot study will explore the benefit of Health Coaching on patients with severe symptoms of COPD.

Detailed Description
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Participants will be randomized to either 12 weeks of weekly telephone health coaching calls followed by 12 weeks of living a normal life or 12 weeks of living a normal life (in addition to 6 brief educational guides and 6 non-health related calls), followed by 12 weeks of health coaching over the phone. Questionnaires and an activity monitor worn for one week will be used at baseline, 3,6 and 12 months.

Official Title
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Mechanistic Effects of Health Coaching to Reduce COPD Hospitalizations

Conditions
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COPD, Emphysema

Intervention / Treatment
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* Behavioral: Health Coaching Calls
* Behavioral: Wait list control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women 40 years or older with a clinical diagnosis of COPD with shortness of breath. Exclusion: terminal illness, inability to communicate by phone

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Control wait design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants in this group will receive 12 weekly health coaching calls followed by 12 weeks of living a normal life. | Behavioral: Health Coaching Calls<br>* 12 weekly health coaching calls<br>|
| Active Comparator: Attention Control<br>Participants in this group will receive 6 educational guides and 6 calls to remind them to read the educational guides (over a 12 week period). The participants will then move to 12 weeks of weekly health coaching calls. | Behavioral: Wait list control<br>* after being 12 week in the usual care arm , patient will compassionately be offered the health coaching intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related Quality of life | Chronic Respiratory questionnaire | Baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health care utilization (hospitalization or ED visits) | COPD exacerbations | Baseline and 3 months | 
| Daily Physical activity | Actigraph monitor | Baseline and 3 months | 
| Self Management | Self Management Ability Scale-30 item questionnaire measuring ability and function. Score range is 0-100, higher score is best. | Baseline and 3 months | 
| Meaning in Life | Meaning in Life MLQ- 10 item questionnaire measures engagement and valued meaning and purpose in life. Scores range from 5-35. The higher the score the more meaning and purpose a person feels in their life. | Baseline and 3 months | 
| Patient Health | Patient Health Questionnaire 9 item questionnaire that screens for the presence of depression. Scores range from 0-27, a higher score suggests the presence of depression. | Baseline and 3 months | 
| Anxiety | GAD-2 item questionnaire that screens for anxiety. Scores range from 0-6, a higher score suggests that anxiety may be present. | Baseline and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health coaching