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Completed

NCT Number: NCT00974246

The Effect on Depressive Symptoms in ECF Residents With COPD

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Behavior Behavioral Symptoms Chronic Disease Depression Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–94 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Geriatric Medical Associates, Brooksville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADVAIR DISKUS

Drug

Advair diskus 50/250 1 inhalation bid for 16 weeks

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Valley Medical Research

Other

Registry information

Official study title

The Effect of Advair Diskus Treatment on Depression in Nursing Home Residents With COPD

Acronym: DISK-02

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 10, 2009
Registry last updated
Dec 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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