Clinical trial NCT01699503: Indiana University Dementia Screening Trial
Official title: Indiana University Dementia Screening Trial: The IU CHOICE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Alzheimer's Disease
Mild Cognitive Impairment
Keywords: Dementia
Alzheimer's Disease
Mild Cognitive Impairment
Screening
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2012-10-03
Enrollment: 4005
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Detailed description: The objective of this proposal is to address the question of whether the benefits outweigh the harms of routine screening for dementia among older adults in primary care when the screening program is coupled with primary care practices prepared to provide care for those who screen positive.

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

Primary Specific Aim 1:

Test the impact of dementia screening on health-related quality of life of the patient at 12 months.

Primary Specific Aim 2:

Test the impact of dementia screening on the mood and anxiety symptoms of patient at 1 month (i.e., primary potential harms).

Secondary Aims: Estimate the cost effectiveness of dementia screening.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Health Related Quality of Life (HRQOL)
timeFrame: 1 month, 6 months, 12 months
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 1 month, 6 months, 12 months
measure: Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: 1 month, 6 months, 12 months
Secondary outcomes:
measure: Number of Participants With Health Care Utilization
timeFrame: 12 months
measure: Number of Participants With an Advance Directive at 12 Months
timeFrame: 12 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Health-Primary Care Clinics
state: Indiana
city: Indianapolis
country: United States
facility: Wishard Health Services-Primary Care Clinics
state: Indiana
city: West Lafayette
country: United States
facility: IU Health Arnett Primary Care Clinics
state: Indiana
Study officials:
affiliation: Regenstrief Institute, Inc.
name: Malaz Boustani, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.