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The Effect on Depressive Symptoms in ECF Residents With COPD (DISK-02)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00974246
First Posted: September 10, 2009
Last Update Posted: December 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Meenakshi Patel, MD, Valley Medical Research
  Purpose
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.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease Depression Drug: Advair diskus Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Advair Diskus Treatment on Depression in Nursing Home Residents With COPD

Resource links provided by NLM:


Further study details as provided by Meenakshi Patel, MD, Valley Medical Research:

Primary Outcome Measures:
  • 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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.


Enrollment: 30
Study Start Date: October 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: COPD, ECF residents, Advair diskus
open label treatment with Advair diskus in COPD patients
Drug: Advair diskus
Advair diskus 50/250 1 inhalation bid for 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

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Ages Eligible for Study:   18 Years to 94 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00974246


Locations
United States, Florida
Geriatric Medical Associates
Brooksville, Florida, United States, 34601
United States, Ohio
Valley Medical Research
Centerville, Ohio, United States, 45459
Sponsors and Collaborators
Valley Medical Research
Investigators
Principal Investigator: Meenakshi Patel, MD Valley Medical Research
  More Information

Responsible Party: Meenakshi Patel, MD, Valley Medical Research
ClinicalTrials.gov Identifier: NCT00974246     History of Changes
Other Study ID Numbers: DISK-02
First Submitted: September 8, 2009
First Posted: September 10, 2009
Results First Submitted: June 15, 2015
Results First Posted: July 2, 2015
Last Update Posted: December 28, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Meenakshi Patel, MD, Valley Medical Research:
COPD
Depression
Nursing Home

Additional relevant MeSH terms:
Depression
Depressive Disorder
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Behavioral Symptoms
Mood Disorders
Mental Disorders
Respiratory Tract Diseases
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics