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Behavioural Intervention

ToolboxDetect Cognitive Screening for Cognitive Impairment

N/A

Recruiting

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 65 years old

Must not have

Severe, uncorrectable vision or hearing impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new strategy for detecting cognitive decline in primary care settings. The strategy, called ToolboxDetect, will provide an efficient and sensitive cognitive screen that can be easily implemented in everyday clinical settings.

Who is the study for?

This trial is for adults aged 65 and older who may or may not have signs of cognitive decline, such as memory loss or confusion. They must be able to see and hear well enough to participate in the tests. Participants will come from practices linked with Northwestern Medicine and Access Community Health Network.

What is being tested?

ToolboxDetect is being tested; it's a new strategy using electronic health records to spot early signs of cognitive decline in diverse primary care settings. It aims to be user-friendly, efficient, and sensitive to concerns about memory problems.

What are the potential side effects?

Since ToolboxDetect involves screening methods rather than medication, traditional side effects are not expected. However, participants might experience stress or discomfort during cognitive testing.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have severe vision or hearing loss that cannot be corrected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of detected impairment

Secondary study objectives

Caregiver involvement

Rate of cognition-related referrals

Rate of cognitive testing

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ToolboxDetect StrategyExperimental Treatment1 Intervention

All practices randomized to the intervention arm will implement the ToolboxDetect battery as the standard of care routine cognitive assessment to fulfill the Medicare Annual Wellness Visit (AWV) requirement. The 7-8 minute ToolboxDetect battery contains self-administered versions of the NIH ToolBox Picture Sequence Memory Test (PSM) and the NIH ToolBox Dimensional Change Card Sorting (DCCS). PSM measures episodic memory and DCCS tests executive functioning. The validated ToolboxDetect application will be imparted either as an application on an iPad or on a PC desktop/laptop computer commonly found in a clinical exam room for EHR access.

Group II: Enhanced Usual CareActive Control1 Intervention

At Northwestern Medicine, cognitive assessments included in Annual Wellness Visits or other routine or sick/problem-based visits vary by practice and also by clinician. However, the choice of test was limited to either a Mini-Cog©, Montreal Cognitive Assessment (MoCA), or Mini Mental Status Exam (MMSE). While we will not make any explicit recommendations to these practices with regard to their use of a cognitive assessment, we will ensure that 1) any chosen test is linked to an Epic SmartData element, which will allow the clinician to record the results of the test as discrete data (which can then be queried), and that 2) providers receive a compiled list of local medical and non-medical referrals for any detected cases of CI. The Alzheimer's Association recommendations for early detection efforts among primary care practices will also be provided to each clinic's medical leadership.

0 / 1Eligibility criteria met