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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD, ECF residents, Advair diskus | Experimental | open label treatment with Advair diskus in COPD patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advair diskus | Drug | Advair diskus 50/250 1 inhalation bid for 16 weeks |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meenakshi Patel, MD | Valley Medical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geriatric Medical Associates | Brooksville | Florida | 34601 | United States | ||
| Valley Medical Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Population: | The study sample (n=27) were nursing home residents with either (1) a confirmed diagnosis of COPD, (2) an FEV1/FVC ratio <0.7 or (3) in treatment with anticholinergic drugs. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Baseline Characteristics | Nursing Home residents with either a confirmed diagnosis of COPD or an FEV1/FVC ratio <0.7 or in treatment with anticholinergic drugs. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 16 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adverse Events | All enrolled subjects. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mental Status Change | Psychiatric disorders | Non-systematic Assessment | Subject was sent to the Emergency Department for mental status changes. He was admitted for tests and observation. He was stabilized and discharged to the Nursing Home. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meenakshi Patel, MD | Valley Medical Research | 937-208-8298 | mpatelmd@ymail.com |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D003863 | Depression |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
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| Centerville |
| Ohio |
| 45459 |
| United States |
| years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 16 weeks |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | ratio | 16 weeks |
|
|
|
| 3 |
| 27 |
| 27 |
| 27 |
|
| Increased Agitation with Combative Behaviors | Psychiatric disorders | Non-systematic Assessment | Subject was sent to the Emergency Department for increased agitation with combative behaviors. She was admitted for observation and psychiatric treatment. She was stabilized and discharged to the Nursing Home. |
|
| Left Above the Knee Amputation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Subject was sent to Emergency Department for possible Deep Vein Thrombosis (DVT). It was determined that she did have a DVT but it was too late to save the leg. An amputation was performed. Subject was stabilized & discharged to the Nursing Home. |
|
| Vitamin D Deficiency | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Bilateral Lower Extremity Edema | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Productive Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pruitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Right Hip Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Increased Aggression | Psychiatric disorders | Non-systematic Assessment |
|
| Increased Restlessness | Psychiatric disorders | Non-systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Urinary Incontinence | Renal and urinary disorders | Non-systematic Assessment |
|
| Dizziness | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Cellulitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Loose stool | Gastrointestinal disorders | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Hypotension | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Leg Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000438 |
| Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000068298 | Fluticasone |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |