The Effect on Depressive Symptoms in ECF Residents With COPD
Information source: Valley Medical Research
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease; Depression
Intervention: Advair diskus (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Valley Medical Research Official(s) and/or principal investigator(s): Meenakshi Patel, MD, Principal Investigator, Affiliation: Valley Medical Research
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.
Clinical Details
Official title: The Effect of Advair Diskus Treatment on Depression in Nursing Home Residents With COPD
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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 3.0To 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. Pulmonary Function FEC/FVC Ratio at 16 Weeks
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 94 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Geriatric Medical Associates, Brooksville, Florida 34601, United States
Valley Medical Research, Centerville, Ohio 45459, United States
Additional Information
Starting date: October 2009
Last updated: June 30, 2015
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