Perceptions Regarding Investigational Screening for Memory Problems in Primary Care - Full Text View

Sponsor:	National Institute on Aging (NIA)
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00759252

Purpose

The purpose of this study is to conduct a cross-sectional survey of primary care patients to better understand their perceptions of the risks and benefits of a screen and subsequent diagnostic confirmation of dementia.

Condition
Dementia

Study Type:	Observational
Study Design:	Cohort, Cross-Sectional
Official Title:	Perceptions Regarding Investigational Screening for Memory Problems in Primary Care: The PRISM-PC Study

Resource links provided by NLM:

MedlinePlus related topics: Dementia Memory

U.S. FDA Resources

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:

Primary care patients' perceptions of the risks and benefits of early identification of dementia [ Time Frame: Measurement will continue through the duration of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluation of the association between primary care patients' acceptance for early identification of dementia and their perceptions of the risks and benefits of such identification after adjusting for potential confounders such as demographics [ Time Frame: Measurement will continue through the duration of the study ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1500
Study Start Date:	February 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Detailed Description:

The Health Belief Model was used to explore the public's acceptance or enthusiasm for early recognition of dementia. Based on this model, prior research and clinical experiences, and a systematic literature review, the PRISM-PC instrument was developed. The PRISM-PC items seek to capture both the patient's acceptance of dementia screening and the patient's perception of potential harms and benefits of such screening. The instrument includes questions regarding screening by performance-based questionnaires, blood tests, or brain imaging.

The PRISM-PC instrument includes 50 items that are organized into 8 sets of questions that cover the following areas:

A) Prior experience with AD (5 items) B) Acceptance of screening for AD (6 items) C) Acceptance of screening for other conditions (2 items) D) Benefits of screening for AD (9 items) E) Stigma of screening for AD (10 items) F) Impact of screening for AD on independence (6 items) G) Suffering of screening for AD (4 items) H) Demographics (7 items) Excluding section A and H (prior experience with AD and demographics), each item of the six other sections is rated on a 5-point Likert scale (strongly agree, agree, don't know, disagree, and strongly disagree).

Based on the previous PRISM-PC pilot study (a survey response rate of 80%) and the Dementia screening and diagnosis study (screening acceptance rate of 90%, positive dementia screening rate of 20% among participants aged 70 and older, and dementia diagnostic acceptance rate of 50%), a total of 1,500 volunteers will be approached. A random selection of 200 participants will be re-administered the questionnaire within one week to test the short-term temporal stability of their responses (test-retest).

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Primary Care Clinic

Criteria

Inclusion Criteria:

Aged 65 and older
At least one office visit to their primary care physician within the last year
No chart-based diagnosis of dementia or memory problem
Willing to sign a consent form to participate in the study

Exclusion Criteria:

Does not speak English
Too hearing-impaired to hear the informed consent statement or the survey
Severe mental illness based on the patient's electronic medical charts

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00759252

Contacts

Contact: Malaz Boustani, MD, MPH	317-423-5633	mboustani@regenstrief.org
Contact: Laura Holtz, BS	317-423-5602	lholtz@regenstrief.org

Locations

United States, Indiana
Indiana University Medical Group	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Malaz A. Boustani, MD, MPH 317-423-5633 mboustani@regenstrief.org
Contact: Laura Holtz 317-423-5602 lholtz@regenstrief.org
Principal Investigator: Malaz Boustani, MD, MPH
Sub-Investigator: Christopher Callahan, MD
Sub-Investigator: Wanzhu Tu, PhD
Sub-Investigator: Hugh Hendrie, MB, ChB, DSc
Sub-Investigator: Fred Unverzagt, PhD

Sponsors and Collaborators

National Institute on Aging (NIA)

Investigators

Principal Investigator:

Malaz Boustani, MD, MPH

Regenstrief Institute, Center for Aging Research

More Information

Publications:

Schubert CC, Boustani M, Callahan CM, Perkins AJ, Hui S, Hendrie HC. Acute Care Utilization by Dementia Caregivers Within Urban Primary Care Practices. J Gen Intern Med. 2008 Aug 9; [Epub ahead of print]

Boustani M, Perkins AJ, Monahan P, Fox C, Watson L, Hopkins J, Fultz B, Hui S, Unverzagt FW, Callahan CM, Hendrie HC. Measuring primary care patients' attitudes about dementia screening. Int J Geriatr Psychiatry. 2008 Aug;23(8):812-20.

Brayne C, Fox C, Boustani M. Dementia screening in primary care: is it time? JAMA. 2007 Nov 28;298(20):2409-11. No abstract available. Erratum in: JAMA. 2008 Feb 13;299(6):634.

Responsible Party:	Regenstrief Institute, Center for Aging Research ( Malaz Boustani, MD, MPH )
Study ID Numbers:	IA0141, 5R01AG029884-02
Study First Received:	September 24, 2008
Last Updated:	June 30, 2009
ClinicalTrials.gov Identifier:	NCT00759252 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

diagnosis of dementia
perceptions of risk
dementia screening

Additional relevant MeSH terms:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases

Central Nervous System Diseases
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on February 08, 2010