Overview

This trial is active, not recruiting.

Conditions dementia, alzheimer's disease, mild cognitive impairment
Treatment collaborative dementia care program
Sponsor Indiana University
Collaborator National Institutes of Health (NIH)
Start date October 2012
End date February 2017
Trial size 4000 participants
Trial identifier NCT01699503, 1R01AG040220-01A1, R01AG040220-01A1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose screening
Arm
(No Intervention)
Subjects who are randomized into the non-screening arm will receive the usual standard of care.
(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.
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.

Primary Outcomes

Measure
Health Related Quality of Life (HRQOL)
time frame: 12 months
Patient Health Questionnaire (PHQ-9)
time frame: 1 month
Generalized Anxiety Disorder Scale (GAD-7)
time frame: 1 month

Secondary Outcomes

Measure
Health Care Utilization
time frame: 12 months
Advanced Care Planning
time frame: 12 months

Eligibility Criteria

Male or female participants at least 65 years old.

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

Additional Information

Official title Indiana University Dementia Screening Trial: The IU CHOICE Study
Principal investigator Malaz Boustani, MD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Indiana University.