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Cognitive Assessment of Elderly Primary Care Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01492335
First Posted: December 14, 2011
Last Update Posted: January 14, 2016
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.
Information provided by (Responsible Party):
University of Pittsburgh
  Purpose
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.

Condition Intervention
Mild Cognitive Impairment Behavioral: Cognitive Report Behavioral: Treatment As Usual

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Cognitive Assessment of Elderly Primary Care Patients

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Scores on a comprehensive battery of neuropsychological tests. [ Time Frame: Two years ]
    Diagnosis is based on performance on a standard neuropsychological test battery that assesses mutliple cognitive domains known to be sensitive to early dementia.


Enrollment: 524
Study Start Date: January 2006
Study Completion Date: August 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Report
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
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
Experimental: Treatment As Usual
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
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).

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492335


Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Judith Saxton, PhD University of Pittsburgh
  More Information

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01492335     History of Changes
Other Study ID Numbers: PCP-AG023129
First Submitted: December 2, 2011
First Posted: December 14, 2011
Last Update Posted: January 14, 2016
Last Verified: January 2016

Keywords provided by University of Pittsburgh:
Cognitive decline
Cognitive impairment

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders