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The Role Of Cognitive Impairment In The Use Of The Diskus Inhaler

This study has been completed.
Sponsor:
Information provided by:
Synergy Health Solutions
ClinicalTrials.gov Identifier:
NCT00891059
First received: April 27, 2009
Last updated: November 22, 2010
Last verified: November 2010
History of Changes
  Purpose

The Diskus Inhaler is administered by a nurse or medical technician in the Nursing Home (NH) setting. The administration of the medication from the Diskus Inhaler includes 4 steps: open, click, inhale, close. The only step that the resident must do is the "inhale" step, which includes holding one's breath for 10 seconds after the inhalation.

The investigators propose that properly trained and motivated nurses and medical technicians can successfully administer medication using the Advair Diskus to almost any mildly to moderately cognitively impaired resident who can follow the instruction- "inhale" and hold your breath for 10 seconds". The objective is to show that mild to moderate cognitive impairment should not be a barrier to the use of Diskus Inhaler. There will only be 1 consent visit and 1 evaluation visit per subject.


Condition
Cognitive Impairment

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: The Role Of Cognitive Impairment In The Use Of The Diskus Inhaler

Resource links provided by NLM:

MedlinePlus related topics: Nursing Homes
U.S. FDA Resources

Further study details as provided by Synergy Health Solutions:

Primary Outcome Measures:
  • The objective is to show that mild to moderate cognitive impairment should not be a barrier to the use of Diskus Inhaler. [ Time Frame: Immediate ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: May 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Placebo Diskus Inhaler

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Nursing Home Residents with Mini Mental Status Exam (MMSE) score between 10 and 24 inclusive with convenience sampling or invitation to volunteer

Criteria

Inclusion Criteria:

  • Adult men and women residing in a NH or ALF
  • Mini Mental Status Exam (MMSE) score between 10 and 24 inclusive
  • Able to hold breath for at least 10 seconds
  • Able to speak and understand English

Exclusion Criteria:

  • Current or history of Diskus use
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00891059

Locations
United States, Florida
Brooksville Health Care Center
Brooksville, Florida, United States, 34601
United States, Ohio
Bethany Village
Centerville, Ohio, United States, 45459
Sponsors and Collaborators
Synergy Health Solutions
Investigators
Principal Investigator: Malcolm R Fraser, MD President, Synergy Health Solutions
  More Information

No publications provided

Responsible Party: Malcolm Fraser, MD, CMD, Synergy Health Solutions
ClinicalTrials.gov Identifier: NCT00891059     History of Changes
Other Study ID Numbers: DISKUS-01
Study First Received: April 27, 2009
Last Updated: November 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Synergy Health Solutions:
Cognitive Impairment
Diskus Inhaler
Nursing Home

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013