Indiana University Dementia Screening Trial (IU-CHOICE)

Indiana University

Status: Completed

Conditions: Alzheimer's Disease; Mild Cognitive Impairment; Dementia

Treatments: Behavioral: Collaborative Dementia Care Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01699503

R01AG040220-01A1

1R01AG040220-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,005 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

4,005 participants in 2 patient groups

No Screening

No Intervention group

Description:

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

Screening Group

Experimental group

Description:

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.

Treatment:

Behavioral: Collaborative Dementia Care Program