NCT01492335

Brief Summary

Most primary care physicians do not screen older patients for cognitive impairment. Identification of cognitive impairment may result in earlier referral for diagnostic work-up and earlier treatment and better patient outcomes. The purpose of this study is to determine whether physicians who receive the results of a cognitive screen use this information in treatment plans and whether this results in better cognitive outcomes for the older patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
524

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 14, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

January 14, 2016

Status Verified

January 1, 2016

Enrollment Period

5.8 years

First QC Date

December 2, 2011

Last Update Submit

January 13, 2016

Conditions

Mild Cognitive Impairment

Keywords

Cognitive declineCognitive impairment

Outcome Measures

Primary Outcomes (1)

  • Scores on a comprehensive battery of neuropsychological tests.

    Diagnosis is based on performance on a standard neuropsychological test battery that assesses mutliple cognitive domains known to be sensitive to early dementia.

    Two years

Study Arms (2)

Cognitive Report

EXPERIMENTAL

Primary care physicians in the Cognitive Report group receive the results of their patients cognitive testing together with clinical diagnosis (Normal, Mild Cognitive Impairment, Dementia) and treatment recommendations.

Behavioral: Cognitive Report

Treatment As Usual

EXPERIMENTAL

Physicians in the Treatment As Usual Group do not receive the results of their patients cognitive assessment, they do not receive treatment recommendations, nor are they told of the patients diagnosis (Normal, Mild Cognitive Impairment, Dementia)

Behavioral: Treatment As Usual

Interventions

Cognitive ReportBEHAVIORAL

Physicians in the Cognitive Report group receive the results of their patients cognitive assessment which includes a clinical diagnosis (Normal, Mild Cognitive Impairment, Dementia) and treatment recommendations

Cognitive Report
Treatment As UsualBEHAVIORAL

Physicians in the Treatment As Usual group do not receive the results of their patients cognitive assessments, they are not given treatment recommendations nor are they told of the patients clinical diagnosis (Normal, Mild Cognitive Impairment, Dementia).

Treatment As Usual

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65 or over
  • Plan to remain a patient of this physician for two years
  • MMSE score greater than 18

You may not qualify if:

  • Diagnosis of Dementia, Alzheimer's disease, Huntington's disease, Vascular disease or other dementing disorder
  • MMSE score of 18 or less
  • Sensory deficit e.g. limited vision or hearing precluding cognitive testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Judith Saxton, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2011

First Posted

December 14, 2011

Study Start

January 1, 2006

Primary Completion

October 1, 2011

Study Completion

August 1, 2012

Last Updated

January 14, 2016

Record last verified: 2016-01

Locations

US(1)