Chronic Obstructive Pulmonary Disease, Depression
Conditions
Keywords
COPD, Depression, Nursing Home
Brief summary
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
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.
Interventions
DRUGAdvair diskus
Advair diskus 50/250 1 inhalation bid for 16 weeks
Sponsors
Valley Medical Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 94 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 16 weeks | 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. |
| 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. | 16 weeks | 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. |
| Pulmonary Function FEC/FVC Ratio at 16 Weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | Baseline Characteristics |
|---|---|
| Age, Continuous | 79.7 years STANDARD_DEVIATION 12.4 |
| Gender Female | 20 Participants |
| Gender Male | 7 Participants |
| Region of Enrollment United States | 27 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 27 / 27 |
| serious Total, serious adverse events | 3 / 27 |
Outcome results
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.
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nursing Home Residents With COPD | Pulmonary Function FEC/FVC Ratio at 16 Weeks | 0.69 ratio | Standard Deviation 0.13 |
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.
Time frame: 16 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nursing Home Residents With COPD | 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. | Section D SUM of the Minimum Data Set | 10.8 units on a scale | Standard Deviation 5 |
| Nursing Home Residents With COPD | 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. | Cornell Depression Scale | 8.7 units on a scale | Standard Deviation 5 |
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.
Time frame: 16 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Nursing Home Residents With COPD | 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 | Cornell Depression Scale | 8.7 units on a scale |
| Nursing Home Residents With COPD | 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 | Section D SUM of the Minimum Data Set 3.0 | 10.8 units on a scale |