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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

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 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

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.

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Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,625 Previous Clinical Trials
895,789 Total Patients Enrolled
7 Trials studying Dementia
58,950 Patients Enrolled for Dementia
ACCESS Community Health NetworkOTHER
6 Previous Clinical Trials
21,239 Total Patients Enrolled

Media Library

ToolboxDetect (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04852601 — N/A
Dementia Research Study Groups: Enhanced Usual Care, ToolboxDetect Strategy
Dementia Clinical Trial 2023: ToolboxDetect Highlights & Side Effects. Trial Name: NCT04852601 — N/A
ToolboxDetect (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04852601 — N/A
~3074 spots leftby Dec 2024
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