Cognitive Risk AssessmentNCT06506877
A Cognitive Risk Calculator and Screening Tool for Primary Care Settings
A study testing Implementation of Cognitive Risk Calculator (RC) and Brief Assessment of Cognitive Health (BACH) in people with Cognitive Risk Assessment, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This mixed-methods pragmatic trial will use a stepped wedge cluster randomized design to implement a cognitive risk-calculator and automated cognitive screening tool (BACH) in eight internal medicine clinics in the Cleveland Clinic Health System. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cognitive Risk Assessment
- What is being tested?
- Implementation of Cognitive Risk Calculator (RC) and Brief Assessment of Cognitive Health (BACH)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Provider sees patients at more than one participating study site.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This mixed-methods pragmatic trial will use a stepped wedge cluster randomized design to implement a cognitive risk-calculator and automated cognitive screening tool (BACH) in eight internal medicine clinics in the Cleveland Clinic Health System. Administrative and EHR data will provide quantitative metrics of adoption (tool use) and effectiveness (change in provider behavior) while observations, interviews, and questionnaires will assess fidelity, acceptability, and feasibility for all stakeholders. Analyses will consider provider characteristics, clinic attributes, and regional variations in patient characteristics (e.g., SES, race/ethnicity).
- Conditions
- Cognitive Risk Assessment
- Being tested
- Implementation of Cognitive Risk Calculator (RC) and Brief Assessment of Cognitive Health (BACH)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of Cognitive Risk Calculator (RC) and Brief Assessment of Cognitive Health (BACH)Behavioural
Enrolled providers will have access to two cognitive screening tools during the active phase. The first tool is a Cognitive Risk-Calculator (RC), integrated into the Electronic Health Record, to help providers identify patients who are at high risk of exhibiting cognitive decline. The second tool is a computerized cognitive screening tool, the Brief Assessment of Cognitive Health (BACH), which patients complete independently. Results are automatically entered into the patient's medical record, along with patient-specific flags for concerns about depression and/or sleep disorder. The purpose of these tools is to facilitate cognitive screening and treatment for factors that may be contributing to cognitive decline.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Active Phase: Implementation of Cognitive Risk Calculator (RC) and Brief Assessment of Cognitive Health (BACH) Receives: Behavioral: Implementation of Cognitive Risk Calculator (RC) and Brief Assessment of Cognitive Health (BACH) |
| Control | No intervention | Control Phase: Prior to implementation of Cognitive Risk Calculator (RC) and Brief Assessment of Cognitive Health (BACH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adoption of RC and BACH: Frequency of Cognitive Screening
Number of cognitive screening events per month, stratified by screening tool (BACH vs other) and Risk Calculator category (high vs low risk).
Measured: Monthly assessment over the study duration (up to 1 year)
Adoption of RC and BACH: Frequency of BACH Orders
Number of BACH orders or pre-visit order sets executed per month, stratified by Risk Calculator category (high vs low risk).
Measured: Monthly assessment over the study duration (up to 1 year)
Effectiveness of RC and BACH: Frequency of MCI/ADRD, Sleep Disorders, and Depression Diagnoses
Incidence of new diagnoses for cognitive impairment (including MCI and ADRD), sleep disorders, and depression per month, stratified by screening completed (BACH/other/none) and Risk Calculator category (high vs low risk).
Measured: Monthly assessment over the study duration (up to 1 year)
Effectiveness of RC and BACH: Frequency of Referrals to Neuropsychology, Geriatrics/Neurology, Psychiatry/Psychology, and Sleep Medicine
Number of orders and consults placed to specialty services per month, stratified by screening completed (BACH/other/none) and Risk Calculator category (high vs low risk).
Measured: Monthly assessment over the study duration (up to 1 year)
Effectiveness of RC and BACH: Prescription Rates for Related Medications
Number of new medication orders relevant to cognition, sleep, and mood per month, stratified by screening completed (BACH/other/none) and Risk Calculator category (high vs low risk).
Measured: Monthly assessment over the study duration (up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start3 Apr 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Risk AssessmentStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Darlene Floden, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506877
- Sponsor's protocol ID
- 20-1022
- Other IDs
- R33AG069729
- Status last verified
- Aug 2026
- First submitted
- 11 Jul 2024
- Last updated
- 24 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 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cognitive Risk Calculator and Screening Tool for Primary Care Settings
- ClinicalTrials.gov ID
- NCT06506877
- Acronym / sponsor ID
- 20-1022
- Conditions
- Cognitive Risk Assessment
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Jul 2024 (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.
This mixed-methods pragmatic trial will use a stepped wedge cluster randomized design to implement a cognitive risk-calculator and automated cognitive screening tool (BACH) in eight internal medicine clinics in the Cleveland Clinic Health System. Administrative and EHR data will provide quantitative metrics of adoption (tool use) and effectiveness (change in provider behavior) while observations, interviews, and questionnaires will assess fidelity, acceptability, and feasibility for all stakeholders. Analyses will consider provider characteristics, clinic attributes, and regional variations in patient characteristics (e.g., SES, race/ethnicity).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Behavioral: Implementation of Cognitive Risk Calculator (RC) and Brief Assessment of Cognitive Health (BACH)Active Phase: Implementation of Cognitive Risk Calculator (RC) and Brief Assessment of Cognitive Health (BACH) |
| Control | No intervention | –Control Phase: Prior to implementation of Cognitive Risk Calculator (RC) and Brief Assessment of Cognitive Health (BACH) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Provider sees patients at more than one participating study site.
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 |
|---|---|---|
| Implementation of Cognitive Risk Calculator (RC) and Brief Assessment of Cognitive Health (BACH)Enrolled providers will have access to two cognitive screening tools during the active phase. The first tool is a Cognitive Risk-Calculator (RC), integrated into the Electronic Health Record, to help providers identify patients who are at high risk of exhibiting cognitive decline. The second tool is a computerized cognitive screening tool, the Brief Assessment of Cognitive Health (BACH), which patients complete independently. Results are automatically entered into the patient's medical record, along with patient-specific flags for concerns about depression and/or sleep disorder. The purpose of these tools is to facilitate cognitive screening and treatment for factors that may be contributing to cognitive decline. | Behavioural | Active |
Primary outcome
Adoption of RC and BACH: Frequency of Cognitive Screening
Time frame: Monthly assessment over the study duration (up to 1 year)
Number of cognitive screening events per month, stratified by screening tool (BACH vs other) and Risk Calculator category (high vs low risk).
Adoption of RC and BACH: Frequency of BACH Orders
Time frame: Monthly assessment over the study duration (up to 1 year)
Number of BACH orders or pre-visit order sets executed per month, stratified by Risk Calculator category (high vs low risk).
Effectiveness of RC and BACH: Frequency of MCI/ADRD, Sleep Disorders, and Depression Diagnoses
Time frame: Monthly assessment over the study duration (up to 1 year)
Incidence of new diagnoses for cognitive impairment (including MCI and ADRD), sleep disorders, and depression per month, stratified by screening completed (BACH/other/none) and Risk Calculator category (high vs low risk).
Effectiveness of RC and BACH: Frequency of Referrals to Neuropsychology, Geriatrics/Neurology, Psychiatry/Psychology, and Sleep Medicine
Time frame: Monthly assessment over the study duration (up to 1 year)
Number of orders and consults placed to specialty services per month, stratified by screening completed (BACH/other/none) and Risk Calculator category (high vs low risk).
Effectiveness of RC and BACH: Prescription Rates for Related Medications
Time frame: Monthly assessment over the study duration (up to 1 year)
Number of new medication orders relevant to cognition, sleep, and mood per month, stratified by screening completed (BACH/other/none) and Risk Calculator category (high vs low risk).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 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.
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 Implementation of Cognitive Risk Calculator (RC) and Brief Assessment of Cognitive Health (BACH) in people with Cognitive Risk Assessment, run by The Cleveland Clinic 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 0 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: enrolling by invitation, as of the sponsor's last update on 24 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?
This study is still under way. Results are not available in the source record yet.
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?
Adoption of RC and BACH: Frequency of Cognitive Screening (time frame: Monthly assessment over the study duration (up to 1 year)). The study lists 5 primary outcomes in all. 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 24 Aug 2026.