Indiana University Dementia Screening Trial

NCT01699503 | Completed Results DMC

• 2 other identifiers: R01AG040220-01A11R01AG040220-01A1
• Study Type: interventional
• Target: 4,005
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of the study is to conduct a randomized clinical trial assessing the harms and benefits of screening for dementia, compared to no screening for dementia, among 4,000 older adults, cared for in typical, primary care practices.

Conditions

Dementia; Alzheimer's Disease; Mild Cognitive Impairment

Keywords

Dementia; Alzheimer's Disease; Mild Cognitive Impairment; Screening

Outcome Measures

Primary Outcomes (3)

• Health Related Quality of Life (HRQOL)

  The primary outcome measure will be the HRQOL measured at baseline, 1, 6 and 12 months among the entire 4,000 enrollees. The study will use the 15-item Health Utility Index (HUI) to determine the subject's HRQOL. The HUI is a generic, utility-based HRQOL instrument applied in patients with a wide range of medical conditions. It has eight attributes: Vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain. The individual health domain scores range from 0.00 (maximum impairment) to 1.00 (no impairment) and the multi-attribute (HUI index) scores, a multiplicative function of individual attribute levels, range from 0.36 to 1.00 with anchors 0.00 = dead and 1.00 = perfect health.

  1 month, 6 months, 12 months

• Patient Health Questionnaire (PHQ-9)

  The PHQ-9 is a nine-item depression scale with a total score from 0 to 27. It has a good internal consistency and test-retest reliability; as well as convergent, construct, criterion, procedural and factorial validity for the diagnosis of major depression. A higher score is associated with more severe depression.

  1 month, 6 months, 12 months

• Generalized Anxiety Disorder Scale (GAD-7)

  The GAD-7 is a seven-item anxiety scale with a total score from 0 to 21. It has a good internal consistency and test-retest reliability; as well as convergent, construct, criterion, procedural and factorial validity for the diagnosis of general anxiety disorder. A higher score is associated with more severe anxiety.

  1 month, 6 months, 12 months

Secondary Outcomes (2)

• Number of Participants With Health Care Utilization

  12 months

• Number of Participants With an Advance Directive at 12 Months

  12 months

Study Arms (2)

No Screening

NO INTERVENTION

Subjects who are randomized into the non-screening arm will receive the usual standard of care.

Screening Group

EXPERIMENTAL

Subjects who are randomized into the screening arm of the study will be screened by the MIS. Subjects with MIS score of less than 5 points will be referred to the Collaborative Dementia Care Program for a subsequent diagnostic assessment, counseling and management.

Behavioral: Collaborative Dementia Care Program

Interventions

Collaborative Dementia Care Program BEHAVIORAL

Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.

Screening Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• adults age 65 and older;
• at least one office visit to their primary care physician within the previous year;
• no previous diagnosis of dementia or memory problem as determined by ICD-9 codes or the presence of prescription for anti-dementia medications (cholinesterase inhibitors or memantine);
• ability to consent to participate in the study; and
• ability to communicate in English

You may not qualify if:

• adults who are a permanent resident of a nursing facility;
• a serious mental illness such as bipolar disorder or schizophrenia as determined by the presence of related ICD-9 codes indicative of such an illness; or
• a pre-existing diagnosis of dementia or cognitive impairment

Sponsors & Collaborators

• Indiana University: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (3)

IU Health-Primary Care Clinics

Indianapolis, Indiana, 46202, United States

Location

Wishard Health Services-Primary Care Clinics

Indianapolis, Indiana, 46202, United States

Location

IU Health Arnett Primary Care Clinics

West Lafayette, Indiana, 47904, United States

Location

Related Publications (6)

• 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.

  PMID: 18232061 BACKGROUND

• Boustani M, Peterson B, Hanson L, Harris R, Lohr KN; U.S. Preventive Services Task Force. Screening for dementia in primary care: a summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2003 Jun 3;138(11):927-37. doi: 10.7326/0003-4819-138-11-200306030-00015.

  PMID: 12779304 BACKGROUND

• Boustani MA, Justiss MD, Frame A, Austrom MG, Perkins AJ, Cai X, Sachs GA, Torke AM, Monahan P, Hendrie HC. Caregiver and noncaregiver attitudes toward dementia screening. J Am Geriatr Soc. 2011 Apr;59(4):681-6. doi: 10.1111/j.1532-5415.2011.03327.x. Epub 2011 Mar 25.

  PMID: 21438862 BACKGROUND

• Fowler NR, Boustani MA, Frame A, Perkins AJ, Monahan P, Gao S, Sachs GA, Hendrie HC. Effect of patient perceptions on dementia screening in primary care. J Am Geriatr Soc. 2012 Jun;60(6):1037-43. doi: 10.1111/j.1532-5415.2012.03991.x.

  PMID: 22690979 BACKGROUND

• Fowler NR, Perkins AJ, Gao S, Sachs GA, Boustani MA. Risks and Benefits of Screening for Dementia in Primary Care: The Indiana University Cognitive Health Outcomes Investigation of the Comparative Effectiveness of Dementia Screening (IU CHOICE)Trial. J Am Geriatr Soc. 2020 Mar;68(3):535-543. doi: 10.1111/jgs.16247. Epub 2019 Dec 2.

  PMID: 31792940 DERIVED

• Fowler NR, Harrawood A, Frame A, Perkins AJ, Gao S, Callahan CM, Sachs GA, French DD, Boustani MA. The Indiana University Cognitive Health Outcomes Investigation of the Comparative Effectiveness of dementia screening (CHOICE) study: study protocol for a randomized controlled trial. Trials. 2014 Jun 6;15:209. doi: 10.1186/1745-6215-15-209.

  PMID: 24903469 DERIVED

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Cognition Disorders

Results Point of Contact

• Title: Dr. Nicole Fowler
• Organization: Indiana University

fowlern@iupui.edu

317-274-9021

Study Officials

• Malaz Boustani, MD, MPH

  Regenstrief Institute, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Regenstrief Institute, IU Center for Aging Research Scientist

Study Record Dates

• First Submitted: September 19, 2012
• First Posted: October 3, 2012
• Study Start: October 1, 2012
• Primary Completion: November 22, 2017
• Study Completion: November 22, 2017
• Last Updated: January 23, 2019
• Results First Posted: January 23, 2019

Record last verified: 2019-01

Locations

US (3)