The Effect on Depressive Symptoms in ECF Residents With COPD

Study Overview
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Brief Summary
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The purpose of this study is to assess the effect of treatment with Advair Diskus on depression using the Cornell depression scale in COPD patients in the nursing home.

Detailed Description
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We are studying 35 residents in the ECF with a diagnosis of COPD. We are evaluating them for depressive symptoms using the Cornell Depression Scale and the MDS 3.0 section D. We are selecting patients who are not currently on treatment with Advair and starting them on Advair Diskus50/250 1 inhalation bid for a period of 16 weeks and reassessing the Cornell Depression SCale and MDS3.0 section D looking for any changes. We are also going to measure FEV1 and FVC using spirometry before treatment and at the end of 16 weeks. This is a pilot study. The numbers are not necessarily adequate to achieve statistical difference-we are looking for trends.

Official Title
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The Effect of Advair Diskus Treatment on Depression in Nursing Home Residents With COPD

Conditions
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Chronic Obstructive Pulmonary Disease, Depression

Intervention / Treatment
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* Drug: Advair diskus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult men and women nursing home residents up to age 95 Stated diagnosis of COPD or FEV1/FVC <0.7 or being treated with an anticholinergic Presence of depressive symptoms as measured on MDS 3.0 Section D SUM Free from conditions likely to be fatal within six months Able to read or understand English Able and willing to provide informed consent or has a guardian/LAR who can provide informed consent Exclusion Criteria: Currently pregnant Unable to read and understand English Free from conditions likely to be fatal within six months Enrolled in hospice New treatment with antidepressant within the last 90 days. Current or recent use (within the last 90 days) of Advair Diskus Unwilling or unable to provide informed consent Expected to be discharged within 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 94 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COPD, ECF residents, Advair diskus<br>open label treatment with Advair diskus in COPD patients | Drug: Advair diskus<br>* Advair diskus 50/250 1 inhalation bid for 16 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Determine the Effect of Treating COPD Patients With Advair Diskus for 16 Weeks on the Cornell Depression Scale or Section D SUM of the Minimum Data Set 3.0 | The Cornell Depression Scale ranges from 0-38, with a score 12 points or more indicating probable depression. Section D SUM o f the Minimum Date Set 3.0 is an assessment tool of health status for all residents (regardless of payer) of long-term care facilities certified to participate in Medicare or Medicaid. Scores range from 0 to 27, with a higher score indicating more depression. | 16 weeks | 
| To Determine if Changes in Pulmonary Function (FEC/FVC) Were Associated With a Reduction in Depression as Assessed by Using the Cornell Depression Scale or Section D SUM of the Minimum Data Set 3.0 During Advair Diskus Treatment. | FEC is Forced Expiratory Capacity and FVC is Forced Vital Capacity. The Cornell Depression Scale ranges from 0-38, with a score 12 points or more indicating probable depression. Section D SUM o f the Minimum Date Set 3.0 is an assessment tool of health status for all residents (regardless of payer) of long-term care facilities certified to participate in Medicare or Medicaid. Scores range from 0 to 27, with a higher score indicating more depression. | 16 weeks | 
| Pulmonary Function FEC/FVC Ratio at 16 Weeks | To measure whether pulmonary function, determined by the ratio between FEC (Forced Expiratory Capacity) and FVC (Forced Vital Capacity), improved during 16 weeks of Advair Diskus administration. | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Depression, Nursing Home