Cognitive DysfunctionNCT04852601
ToolBox Detect: Low Cost Detection of Cognitive Decline in Primary Care Settings
A study testing ToolboxDetect in people with Cognitive Dysfunction and Dementia, run by Northwestern University at 1 site in United States.
Trial summary
Our study objective is to widely implement and evaluate a user-centered, scalable, electronic health record (EHR)-linked strategy for the routine detection of cognitive decline among diverse primary care settings. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Dysfunction, Dementia
- What is being tested?
- ToolboxDetect
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35,403 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2022to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Individuals aged 65 and older will be considered.
- Adults who may or may not have cognitive impairments.
- Practices affiliated with Northwestern Medicine and Access Community Health Network.
Who cannot join
- 1. Severe, uncorrectable vision or hearing impairment
Trial locations and contacts
1 site in 1 country.
About this study
Our study objective is to widely implement and evaluate a user-centered, scalable, electronic health record (EHR)-linked strategy for the routine detection of cognitive decline among diverse primary care settings. This strategy, called ToolboxDetect, will provide an efficient and sensitive cognitive screen that can be easily implemented in everyday clinical settings, and is responsive to patient, family, and caregiver concerns for potential symptoms of cognitive decline (CD) and cognitive impairment (CI).
Read the detailed description
Our study objective is to widely implement and evaluate a user-centered, scalable, electronic health record (EHR)-linked strategy for the routine detection of cognitive decline among diverse primary care settings. We will conduct a large-scale, primary care practice-randomized trial to implement and comprehensively evaluate ToolboxDetect as a standard of care with AWVs, linked to an EHR (Epic). Diverse, academic and community settings are included to optimize future dissemination efforts.
ToolboxDetect is an iPad-based, self-administered assessment that leverages two well validated measures from the NIH Toolbox Cognition Battery: Dimensional Change Card Sorting (for executive function) and the Picture Sequence Memory (for episodic memory). It takes approximately 7-8 minutes to administer, and for practices randomized to the ToolboxDetect arm, this will be used as the practice standard to fulfill the requirement for cognitive testing as part of the Medicare Annual Wellness Visit (AWV).
The aims of our investigation are to:
- Evaluate the effectiveness of ToolboxDetect, compared to enhanced usual care, to promote timely detection of cognitive decline and its care management.
- Disseminate and implement ToolboxDetect among a large Federally Qualified Health Center Network and assess its feasibility and acceptability for use;
- Investigate the fidelity of ToolboxDetect, and identify any patient, caregiver, healthcare provider and/or system barriers to its optimal, sustained implementation;
- Determine costs associated with implementing ToolboxDetect from a primary care perspective.
- Conditions
- Cognitive Dysfunction, Dementia
- Being tested
- ToolboxDetect
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToolboxDetectOther
The clinician or staff member will identify the patient by either scanning a barcode or entering his/her name, age and medical record number on an administrative screen (allowing for proper routing of test results). After completing the test, a 'submit' button will automatically generate a secure HL7 message, sharing 1) a binary classification of the results ('impaired cognition' or 'normal function'), 2) the quantitative ToolboxDetect score, and 3) brief clinical decision support to rule out any reversible causes. These results will be linked to a discrete, queriable, Epic SmartData element. As patients undergo multiple AWVs over time, ToolboxDetect quantitative scores will be displayed in Epic Synopsis Activity, a graphical display that can visualize trend data (e.g. patient vitals) and calculate a percentage change from the prior year. This will allow a clinician to establish a patient's own baseline (instead of using normative data only) for reference.
| Study group | Role | What they receive |
|---|---|---|
| ToolboxDetect Strategy | Experimental | 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. Receives: Other: ToolboxDetect |
| Enhanced Usual Care | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of detected impairment
This will be operationalized as either results of an any administered cognitive test suggesting impairment ('detected'), or having any relevant ICD 10 classification code recorded in a patient's record after the trial launch date and throughout follow-up observation period ('diagnosis').
Measured: Up to 3 years
Secondary outcomes (4)
Rate of cognitive testing
Extraction from the enterprise data warehouse (EDW) of elements used to document cognitive assessment
Measured: Up to 3 years
Rate of detected cases with mild impairment
Mild vs. other impairment rates will be compared across trial arms, operationalized by ICD code groupings.
Measured: Up to 3 years
Rate of cognition-related referrals
Extraction from the electronic data warehouse for whether or not a cognitive-related referral was made (medical or non-medical) following a "detected" cognitive screen
Measured: Up to 3 years
Caregiver involvement
Text search of clinic note from any follow-up visit post AWV, wellness visit mention of accompanying family member/caregiver; extraction from EDW to determine if proxy access to patient's MyChart portal has been shared.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start25 Aug 2022
- Primary completion28 Feb 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 35,403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- ACCESS Community Health Network
- Responsible party
- Principal investigator, Michael S. Wolf, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852601
- Sponsor's protocol ID
- R01AG069762
- Status last verified
- Mar 2026
- First submitted
- 14 Apr 2021
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ToolBox Detect: Low Cost Detection of Cognitive Decline in Primary Care Settings
- ClinicalTrials.gov ID
- NCT04852601
- Acronym / sponsor ID
- R01AG069762
- Conditions
- Cognitive Dysfunction, Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35,403 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- ACCESS Community Health Network
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our study objective is to widely implement and evaluate a user-centered, scalable, electronic health record (EHR)-linked strategy for the routine detection of cognitive decline among diverse primary care settings. This strategy, called ToolboxDetect, will provide an efficient and sensitive cognitive screen that can be easily implemented in everyday clinical settings, and is responsive to patient, family, and caregiver concerns for potential symptoms of cognitive decline (CD) and cognitive impairment (CI).
Detailed description
Our study objective is to widely implement and evaluate a user-centered, scalable, electronic health record (EHR)-linked strategy for the routine detection of cognitive decline among diverse primary care settings. We will conduct a large-scale, primary care practice-randomized trial to implement and comprehensively evaluate ToolboxDetect as a standard of care with AWVs, linked to an EHR (Epic). Diverse, academic and community settings are included to optimize future dissemination efforts.
ToolboxDetect is an iPad-based, self-administered assessment that leverages two well validated measures from the NIH Toolbox Cognition Battery: Dimensional Change Card Sorting (for executive function) and the Picture Sequence Memory (for episodic memory). It takes approximately 7-8 minutes to administer, and for practices randomized to the ToolboxDetect arm, this will be used as the practice standard to fulfill the requirement for cognitive testing as part of the Medicare Annual Wellness Visit (AWV).
The aims of our investigation are to:
- Evaluate the effectiveness of ToolboxDetect, compared to enhanced usual care, to promote timely detection of cognitive decline and its care management.
- Disseminate and implement ToolboxDetect among a large Federally Qualified Health Center Network and assess its feasibility and acceptability for use;
- Investigate the fidelity of ToolboxDetect, and identify any patient, caregiver, healthcare provider and/or system barriers to its optimal, sustained implementation;
- Determine costs associated with implementing ToolboxDetect from a primary care perspective.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ToolboxDetect Strategy | Experimental | Other: ToolboxDetectAll 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. |
| Enhanced Usual Care | No 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Individuals aged 65 and older will be considered.
- Adults who may or may not have cognitive impairments.
- Practices affiliated with Northwestern Medicine and Access Community Health Network.
Key exclusion criteria (1 listed)
- 1. Severe, uncorrectable vision or hearing impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ToolboxDetectThe clinician or staff member will identify the patient by either scanning a barcode or entering his/her name, age and medical record number on an administrative screen (allowing for proper routing of test results). After completing the test, a 'submit' button will automatically generate a secure HL7 message, sharing 1) a binary classification of the results ('impaired cognition' or 'normal function'), 2) the quantitative ToolboxDetect score, and 3) brief clinical decision support to rule out any reversible causes. These results will be linked to a discrete, queriable, Epic SmartData element. As patients undergo multiple AWVs over time, ToolboxDetect quantitative scores will be displayed in Epic Synopsis Activity, a graphical display that can visualize trend data (e.g. patient vitals) and calculate a percentage change from the prior year. This will allow a clinician to establish a patient's own baseline (instead of using normative data only) for reference. | Other | ToolboxDetect Strategy |
Primary outcome
Rate of detected impairment
Time frame: Up to 3 years
This will be operationalized as either results of an any administered cognitive test suggesting impairment ('detected'), or having any relevant ICD 10 classification code recorded in a patient's record after the trial launch date and throughout follow-up observation period ('diagnosis').
4 secondary outcomes
Rate of cognitive testing
Time frame: Up to 3 years
Rate of detected cases with mild impairment
Time frame: Up to 3 years
Rate of cognition-related referrals
Time frame: Up to 3 years
Caregiver involvement
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ToolboxDetect in people with Cognitive Dysfunction and Dementia, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of detected impairment (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.