Use of Respiratory Therapists (RTs) to Improve Outcomes and Quality of Life in Patients With COPD

Study Overview
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Brief Summary
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Evaluate subjects in an prospective randomized controlled trial in which subjects will be administered scientifically validated questionnaires to determine the effect of the education and case management by Respiratory Therapists (RTs) on improvements in: health outcomes and quality of life as primary endpoints Utilize: Chronic Respiratory Disease Questionnaire (CRQ) The secondary endpoints will be: Rate of exacerbation's, Health care utilization (emergency room encounters, hospital admissions)

Detailed Description
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Evaluate subjects in an prospective randomized controlled trial in which subjects will be screened and administered scientifically validated questionnaires at study entry and during the observation period at specified intervals to determine the effect of the education and case management by Respiratory Therapists (RTs) on improvements in health outcomes and quality of life as primary endpoints, utilizing the Chronic Respiratory Disease Questionnaire (CRQ). The secondary endpoints will be rate of exacerbation's and health care utilization (emergency room encounters, hospital admissions).

Official Title
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A Prospective Randomized Controlled Trial to Evaluate the Use of Respiratory Therapists (RTs) to Improve Outcomes and Quality of Life in Patients Diagnosed With COPD

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Other: Respiratory Therapist Education and Case Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of COPD Cognitive ability to retain education and training Resides in a stable residence or home, apartment Managed by primary care physician (family practice) Exclusion Criteria: Lacks cognitive ability to retain education and training Not managed by primary care physician (family practice) No stable residence or is homeless

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COPD, Education and Case Management<br>Respiratory Therapist Education and Case Management | Other: Respiratory Therapist Education and Case Management<br>* Respiratory Therapists will conduct home care visits over a period of one-year at two-week intervals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Using Chronic Respiratory Disease Questionnaire | Using the CRQ Evaluate Health Outcomes and QOL | Measure Dyspnea at baseline upon study entry and change from baseline every two weeks up to three months; Numerical, 7-point modified Likert Scale; Total score and subscores on categories; higher scores indicate better health-related quality of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare Utilization | Hospital Admission, Emergency Room Encounters | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Respiratory Therapist, Case Management, Education