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Identifying Patients With Dementia in Primary Care (GEMS)

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.
 
ClinicalTrials.gov Identifier: NCT00289471
Recruitment Status : Completed
First Posted : February 9, 2006
Results First Posted : August 26, 2014
Last Update Posted : May 1, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Observational
Study Design Time Perspective: Cross-Sectional
Conditions Dementia
Memory Disorders
Intervention Other: No intervention delivered.
Enrollment 630
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cognitive Screening
Hide Arm/Group Description

Cognitive screening

No intervention delivered.: No intervention delivered.

Period Title: Overall Study
Started 630
Completed 630
Not Completed 0
Arm/Group Title Cognitive Screening
Hide Arm/Group Description

Cognitive screening

No intervention delivered.: No intervention delivered.

Overall Number of Baseline Participants 630
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 630 participants
74.8  (6.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 630 participants
Female
45
   7.1%
Male
585
  92.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 630 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
165
  26.2%
White
461
  73.2%
More than one race
0
   0.0%
Unknown or Not Reported
4
   0.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 630 participants
630
1.Primary Outcome
Title Performance Characteristics
Hide Description Sensitivity and Specificity for Modified Mini-Mental Status Examination (MMSE), a measure scored 0-100 to assess cognitive impairment
Time Frame Cross-sectional [at baseline; no longitudinal component]
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Screening
Hide Arm/Group Description:

Cognitive screening

No intervention delivered.: No intervention delivered.

Overall Number of Participants Analyzed 630
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Sensitivity (%)
86
(64 to 95)
Specificity (%)
79
(72 to 82)
Time Frame Cross-sectional [at baseline; no longitudinal component]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cognitive Screening
Hide Arm/Group Description

Cognitive screening

No intervention delivered.: No intervention delivered.

All-Cause Mortality
Cognitive Screening
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Cognitive Screening
Affected / at Risk (%)
Total   0/630 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cognitive Screening
Affected / at Risk (%)
Total   0/630 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John W. Williams
Organization: Durham VAMC
Phone: 919-286-6963
EMail: jw.williams@duke.edu
Layout table for additonal information
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00289471    
Other Study ID Numbers: IIR 05-112
First Submitted: February 8, 2006
First Posted: February 9, 2006
Results First Submitted: August 11, 2014
Results First Posted: August 26, 2014
Last Update Posted: May 1, 2015