Perceptions Regarding Investigational Screening for Memory Problems in Primary Care (PRISM-PC)

• ClinicalTrials.gov Identifier: NCT00759252
• Recruitment Status: Completed
• First Posted: September 25, 2008
• Last Update Posted: August 28, 2015
• Sponsor: Indiana University
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): Malaz Boustani, MD, MPH, Indiana University

Study Description

Brief Summary:

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 or disease
Dementia

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).

Study Design

• Study Type: Observational
• Actual Enrollment: 954 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Perceptions Regarding Investigational Screening for Memory Problems in Primary Care: The PRISM-PC Study
• Study Start Date: February 2008
• Actual Primary Completion Date: May 2011
• Actual Study Completion Date: May 2011

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Indiana

Indiana University Medical Group

Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

Indiana University

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 Nov;23(11):1736-40. doi: 10.1007/s11606-008-0711-0. Epub 2008 Aug 9.

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. doi: 10.1002/gps.1983.

Brayne C, Fox C, Boustani M. Dementia screening in primary care: is it time? JAMA. 2007 Nov 28;298(20):2409-11. Erratum in: JAMA. 2008 Feb 13;299(6):634.

• Responsible Party: Malaz Boustani, MD, MPH, Regenstrief Institute, IU Center for Aging Research Scientist, Indiana University
• ClinicalTrials.gov Identifier: NCT00759252
• Other Study ID Numbers: IA0141; R01AG029884 ( U.S. NIH Grant/Contract ); 5R01AG029884-02 ( U.S. NIH Grant/Contract )
• First Posted: September 25, 2008
• Last Update Posted: August 28, 2015
• Last Verified: August 2015

Keywords provided by Malaz Boustani, MD, MPH, Indiana University:

diagnosis of dementia; perceptions of risk; dementia screening

Additional relevant MeSH terms:

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders