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

Primary Purpose

Chronic Obstructive Pulmonary Disease, Depression

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Advair diskus
Sponsored by
Valley Medical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Depression, Nursing Home

Eligibility Criteria

18 Years - 94 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Geriatric Medical Associates
  • Valley Medical Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

COPD, ECF residents, Advair diskus

Arm Description

open label treatment with Advair diskus in COPD patients

Outcomes

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
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.
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
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.

Secondary Outcome Measures

Full Information

First Posted
September 8, 2009
Last Updated
November 4, 2016
Sponsor
Valley Medical Research
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1. Study Identification

Unique Protocol Identification Number
NCT00974246
Brief Title
The Effect on Depressive Symptoms in ECF Residents With COPD
Acronym
DISK-02
Official Title
The Effect of Advair Diskus Treatment on Depression in Nursing Home Residents With COPD
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Valley Medical Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Depression
Keywords
COPD, Depression, Nursing Home

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COPD, ECF residents, Advair diskus
Arm Type
Experimental
Arm Description
open label treatment with Advair diskus in COPD patients
Intervention Type
Drug
Intervention Name(s)
Advair diskus
Intervention Description
Advair diskus 50/250 1 inhalation bid for 16 weeks
Primary Outcome Measure Information:
Title
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
Description
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
Title
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.
Description
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
Title
Pulmonary Function FEC/FVC Ratio at 16 Weeks
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
94 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meenakshi Patel, MD
Organizational Affiliation
Valley Medical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geriatric Medical Associates
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
Facility Name
Valley Medical Research
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect on Depressive Symptoms in ECF Residents With COPD

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