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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of detected impairment
Secondary outcome measures
Caregiver involvement
Rate of cognition-related referrals
Rate of cognitive testing
+1 moreTrial 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
1,586 Previous Clinical Trials
875,519 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I may or may not have issues with my memory or thinking.I am 65 years old or older.I have severe vision or hearing loss that cannot be corrected.I may or may not have issues with my memory or thinking.I am 65 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Enhanced Usual Care
- Group 2: ToolboxDetect Strategy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the estimated aggregate of participants for this clinical experiment?
"Indeed. According to the information found on clinicaltrials.gov, this research is currently recruiting participants with an initial posting date of August 25th 2022 and a most recent edit occuring September 21st 2022. A total of 41500 test subjects need to be enrolled from 1 medical facility."
Answered by AI
Is there still capacity for patient participation in this research endeavor?
"Affirmative. Clinicaltrials.gov carries evidence that this clinical trial is still recruiting participants, despite being posted on August 25th 2022 and last edited on September 21st 2022. 41,500 individuals need to be enrolled from one single medical centre."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
What site did they apply to?
Northwestern University
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
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