Cognitive Assessment of Elderly Primary Care Patients
Primary Purpose
Mild Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Report
Treatment As Usual
Sponsored by

About this trial
This is an interventional screening trial for Mild Cognitive Impairment focused on measuring Cognitive decline, Cognitive impairment
Eligibility Criteria
Inclusion Criteria:
- Age 65 or over
- Plan to remain a patient of this physician for two years
- MMSE score greater than 18
Exclusion Criteria:
- 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
Sites / Locations
- University of Pittsburgh
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cognitive Report
Treatment As Usual
Arm Description
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.
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)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01492335
First Posted
December 2, 2011
Last Updated
January 13, 2016
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT01492335
Brief Title
Cognitive Assessment of Elderly Primary Care Patients
Official Title
Cognitive Assessment of Elderly Primary Care Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Current trends in healthcare suggest that in the coming decade most older patients will obtain services solely through the general practice/family practice sector of healthcare. Effective and optimal management of older patients with multiple complex medical conditions and compromised cognitive functioning will be a challenge for the primary care physician (PCP). Early identification of older patients with cognitive deficits should allow early referral for diagnostic work-up and earlier treatment and better patient outcomes. The goal of this study is to investigate the utility of providing cognitive testing in the PCP office. PCPs will be randomized to either Treatment As Usual (TAU) or Cognitive Report (CR). The study hypotheses are (1) patients of physicians in the CR group will have improved clinical outcomes i.e. cognitively impaired patients in the CR group will have a slower rate of progression of cognitive deficits over two years than cognitively impaired patients in the TAU group; (2) PCPs in the CR group will order dementia screening tests, refer to specialists and prescribe anticholinesterase inhibitors more frequently than PCPs in the TAU group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Cognitive decline, Cognitive impairment
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
524 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Report
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment As Usual
Arm Type
Experimental
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Report
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Treatment As Usual
Intervention Description
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).
Primary Outcome Measure Information:
Title
Scores on a comprehensive battery of neuropsychological tests.
Description
Diagnosis is based on performance on a standard neuropsychological test battery that assesses mutliple cognitive domains known to be sensitive to early dementia.
Time Frame
Two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 65 or over
Plan to remain a patient of this physician for two years
MMSE score greater than 18
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Saxton, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cognitive Assessment of Elderly Primary Care Patients
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