Perceptions Regarding Investigational Screening for Memory Problems in Primary Care

Dementia Clinical Trial

— PRISM-PC  

Official title:

Perceptions Regarding Investigational Screening for Memory Problems in Primary Care: The PRISM-PC Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00759252
• Other study ID #: IA0141
• Secondary ID: R01AG0298845R01A
• Status: Completed
• Phase: N/A
• First received: September 24, 2008
• Last updated: August 27, 2015
• Start date: February 2008
• Est. completion date: May 2011

Study information

• Verified date: August 2015
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 954
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Dementia

Locations

Country	Name	City	State
United States	Indiana University Medical Group	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary care patients' perceptions of the risks and benefits of early identification of dementia		Measurement will continue through the duration of the study	No
Secondary	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		Measurement will continue through the duration of the study	No