Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
4005 participants
INTERVENTIONAL
2012-10-31
2017-11-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Caregiver Outcomes of Alzheimer's Disease Screening
NCT03300180
Alzheimer's Disease Multiple Intervention Trial
NCT01314950
Technology Intervention to Support Caregiving for Alzheimer's Disease (I-CARE)
NCT03119259
Patient Priorities Care Among Persons Living With Mild Cognitive Impairment and Dementia
NCT06001775
I-CARE 2: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms
NCT05733520
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
No Screening
Subjects who are randomized into the non-screening arm will receive the usual standard of care.
No interventions assigned to this group
Screening Group
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.
Collaborative Dementia Care Program
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Collaborative Dementia Care Program
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institutes of Health (NIH)
NIH
National Institute on Aging (NIA)
NIH
Indiana University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nicole R. Fowler, PhD
Regenstrief Institute, IU Center for Aging Research Scientist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Malaz Boustani, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Regenstrief Institute, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
IU Health-Primary Care Clinics
Indianapolis, Indiana, United States
Wishard Health Services-Primary Care Clinics
Indianapolis, Indiana, United States
IU Health Arnett Primary Care Clinics
West Lafayette, Indiana, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.