Cognitive Assessment of Elderly Primary Care Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by University of Pittsburgh.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01492335
First received: December 2, 2011
Last updated: December 13, 2011
Last verified: December 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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
Estimated 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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01492335     History of Changes
Other Study ID Numbers: PCP-AG023129
Study First Received: December 2, 2011
Last Updated: December 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Cognitive decline
Cognitive impairment

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014