The Effect on Depressive Symptoms in ECF Residents With COPD

Phase 4

Completed

Conditions: Depression
Chronic Obstructive Pulmonary Disease

Interventions: Drug: Advair diskus

Registration Number: NCT00974246

Lead Sponsor: Valley Medical Research

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COPD, ECF residents, Advair diskus	Advair diskus	open label treatment with Advair diskus in COPD patients

Primary Outcome Measures

Name	Time	Method
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.
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.