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

This study has been completed.
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00759252
First received: September 24, 2008
Last updated: May 26, 2011
Last verified: May 2011
History of Changes
  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: Observational Model: Cohort
Time Perspective: 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 Indiana University:

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 ]
Estimated Enrollment: 1500
Study Start Date: February 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (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
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: NCT00759252

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:

Responsible Party: Malaz Boustani, MD, MPH, Regenstrief Institute, Center for Aging Research
ClinicalTrials.gov Identifier: NCT00759252     History of Changes
Other Study ID Numbers: IA0141, R01AG029884, 5R01AG029884-02
Study First Received: September 24, 2008
Last Updated: May 26, 2011
Health Authority: United States: Federal Government

Keywords provided by Indiana University:
diagnosis of dementia
perceptions of risk
dementia screening

ClinicalTrials.gov processed this record on March 03, 2015