NCT00891059

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2009

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2009

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

November 23, 2010

Status Verified

November 1, 2010

Enrollment Period

2 months

First QC Date

April 27, 2009

Last Update Submit

November 22, 2010

Conditions

Cognitive Impairment

Keywords

Cognitive ImpairmentDiskus InhalerNursing Home

Outcome Measures

Primary Outcomes (1)

  • The objective is to show that mild to moderate cognitive impairment should not be a barrier to the use of Diskus Inhaler.

    Immediate

Study Arms (1)

Placebo Diskus Inhaler

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Current or history of Diskus use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brooksville Health Care Center

Brooksville, Florida, 34601, United States

Location

Bethany Village

Centerville, Ohio, 45459, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Malcolm R Fraser, MD

    President, Synergy Health Solutions

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 27, 2009

First Posted

April 30, 2009

Study Start

May 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

November 23, 2010

Record last verified: 2010-11

Locations

US(2)