NCT00289471

Brief Summary

Veterans who completed GEMS-Phase 1 will be asked to participate in GEMS-Phase 2 to determine the accuracy of methods used to assess mild memory problems. This will better help us evaluate the screening test completed in GEMS-Phase 1. The goals are:

  1. 1.Compare the assessment of memory made at the initial visit to assessments of memory made at the second evaluation.
  2. 2.Determine of veterans with mild memory problems have improvement or worsening of these memory problems over time. Our long-term goal remains to optimize the quality of care for veterans with cognitive impairment. We will also determine if patient characteristics can be used to target case-finding, describe the current process of care and evaluate the association between cognitive impairment and overall- and dementia-related health care utilization and costs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
630

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

February 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2006

Completed
3.6 years until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

August 26, 2014

Completed
Last Updated

May 1, 2015

Status Verified

April 1, 2015

Enrollment Period

2 months

First QC Date

February 8, 2006

Results QC Date

August 11, 2014

Last Update Submit

April 10, 2015

Conditions

Keywords

Sensitivity and specificityPhysician's practice patternsHealth Care costsQuality of Health Care

Outcome Measures

Primary Outcomes (1)

  • Performance Characteristics

    Sensitivity and Specificity for Modified Mini-Mental Status Examination (MMSE), a measure scored 0-100 to assess cognitive impairment

    Cross-sectional [at baseline; no longitudinal component]

Study Arms (1)

Cognitive Screening

Cognitive screening

Other: No intervention delivered.

Interventions

No intervention delivered.

Cognitive Screening

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Veterans' who have previously completed GEMS-Phase 1 testing, continues to be a VA clinic patient and identifies a key family member or friend who will answer questions about the veteran's memory and daily activities.

You may qualify if:

  • Previous participant who completed GEMS-Phase 1
  • Continues to be a VA clinic patient
  • Identifies a key informant with phone

You may not qualify if:

  • Severe hearing or visual impairment
  • Acute medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Durham VA Medical Center HSR&D COE

Durham, North Carolina, 27705, United States

Location

Related Publications (2)

  • Plassman BL, Williams JW Jr, Burke JR, Holsinger T, Benjamin S. Systematic review: factors associated with risk for and possible prevention of cognitive decline in later life. Ann Intern Med. 2010 Aug 3;153(3):182-93. doi: 10.7326/0003-4819-153-3-201008030-00258. Epub 2010 Jun 14.

  • Holsinger T, Plassman BL, Stechuchak KM, Burke JR, Coffman CJ, Williams JW Jr. Screening for cognitive impairment: comparing the performance of four instruments in primary care. J Am Geriatr Soc. 2012 Jun;60(6):1027-36. doi: 10.1111/j.1532-5415.2012.03967.x. Epub 2012 May 30.

MeSH Terms

Conditions

DementiaMemory DisordersHypersensitivity

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsImmune System Diseases

Results Point of Contact

Title
John W. Williams
Organization
Durham VAMC

Study Officials

  • John W Williams, MD MHS

    Durham VA Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2006

First Posted

February 9, 2006

Study Start

October 1, 2009

Primary Completion

December 1, 2009

Study Completion

October 1, 2010

Last Updated

May 1, 2015

Results First Posted

August 26, 2014

Record last verified: 2015-04

Locations