ClinicalTrials.gg
RecruitingNCT07812337Updated Oct 28, 2026

Evaluation of a Decision-Support Tool for Blood Biomarker Testing for Alzheimer's Disease in Primary Care

An interventional study of Shared decision-making support tool in Cognitive Abnormality, sponsored by University of Wisconsin, Madison. Recruiting at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Oct 2026; still recruiting 1 month later.
Updated Oct 28, 2026Now RecruitingStart date moved+1 moreGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 24 studies in Alzheimer Disease by University of Wisconsin, Madison — 6 open to participants now, 6 under way, none of them phase 3. Alzheimer Disease · University of Wisconsin, Madison.

Planned enrollment
8th of 17
70 · median 42
Started
2026
with 2 others
No phase
6 of 24
2 open now
Registered
24th of 24
by date

Among the 24 studies in Alzheimer Disease by University of Wisconsin, Madison, this one is the 8th largest by planned enrollment of the 17 interventional ones that give a count, is one of 3 that started in 2026, is one of 6 with no phase, and was the 24th registered.

Alzheimer Disease

3,968 studies on the registry are indexed under Alzheimer Disease; 928 are open to participants now.

Browse Alzheimer Disease studies →

Open to participants now

6 of the 24 studies in Alzheimer Disease by University of Wisconsin, Madison are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 6 open studies →

Where they have run

Who these studies take

Of the 643 Alzheimer Disease studies recruiting now, 284 (44%) set no upper age limit and 55 (9%) stop at 75 or younger; 34 take children under 18; 285 take healthy volunteers.

This study: 50 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 24 studies in Alzheimer Disease by University of Wisconsin, Madison, or all of them as a file.
02

Study summary

The goal of the current study is to evaluate a decision-support tool intended to help primary care providers (PCPs) communicate with patients about blood biomarker testing for Alzheimer's Disease, enhancing shared-decision making and information sharing in the clinical space. The main questions it aims to answer are:

  • Is the decision-support tool accepted and easy to use for PCPs?
  • Does using the tool improve shared decision-making during clinical encounters? Researchers will compare clinical encounters between PCPs who do not use the tool to discuss blood biomarker testing for Alzheimer's Disease, versus PCPs who have been trained to utilize the tool during clinical encounters to see whether the tool effectively facilitates shared-decision making.
Read the detailed description

This pilot study will determine the acceptability and usability of a decision-support tool for primary care providers (PCPs) and assess the feasibility of recruitment techniques in preparation for a later trial. The study includes two high-fidelity simulation components.

Simulation 1: The investigators will assess the usability and acceptability of the decision-support tool through direct observation and surveys of PCPs participating in high-fidelity simulations of clinical encounters (N=15). The hypothesis is that the decision-support tool will be acceptable and usable by PCPs.

Simulation 2: The investigators will compare the effect of the decision-support tool on shared decision-making (SDM) in high-fidelity simulated clinical encounters conducted with the tool versus without the tool (N=25 per arm). The hypothesis is that shared decision-making will increase in encounters using the intervention.

03

Conditions studied

  • Cognitive Abnormality

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Keywords

  • Alzheimer's Disease
  • Blood Biomarker Testing
  • Shared Decision-Making
04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • Simulation 1 and Simulation 2: PCPs with experience and interest in cognitive diagnosis.
  • Simulation 2: community dwelling older adults age 50 or older are eligible.

Exclusion Criteria (PCP): none

Participant Exclusion Criteria:

  • Not fluent in English
  • age \<50 years
  • pre-existing diagnosis of cognitive impairment
  • having an activated medical decision-make r or not living independently in the community.

There will be no exclusion based upon sex/gender, race, or ethnicity.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Simulation clinical encounters

    In Simulation 1, 15 PCPs will complete simulated clinical encounters with standardized patients after completing trainings on how to use the decision-support tool. In Simulation 2, a different group of 3-5 PCPs will see patients during simulated clinical encounters without using the decision-support too for the first half. In the second half, these PCPs will complete trainings on how to use the tool and then see the second half of the participants using the tool.

    Other: Shared decision-making support tool

Interventions

  • OtherShared decision-making support tool

    Based on previous data analysis, the decision-support tool is intended to facilitate discussions between the patients and their providers regarding the Phospho-Tau blood test. It functions as a flowchart to provide clear, accessible information about the blood test that will assist providers in discussions around guide the patients through navigating a diagnostic workups for memory problems.

06

What researchers measure

Primary outcomes

  1. Effectiveness of the tool on shared decision-making as measured by OPTION-5 Score

    Effectiveness of the tool on shared decision-making will be measured by OPTION-5 score, a validated measurement to quantitatively evaluated shared decision-making process from the observers' perspective. The total range of scores is from 0-100 where higher scores indicate greater patient involvement

    Time frame: This is a single time point outcome measure. In Simulation 2, providers participants will complete OPTION-5 immediately after they participate in the high fidelity clinical encounter session.

  2. Effectiveness of the tool on shared decision-making assessed by SDM-Q-9.

    SDM-Q-9 is a 9-item questionnaire that evaluates the shared decision-making (SDM) process from the patient's perspective. Individual items range from "completely disagree" (0) to "completely agree" (5), yielding a raw sum score between 0 and 45, where higher scores demonstrate increased effectiveness.

    Time frame: This is a single time point outcome measure. In Simulation 2, patients participants will complete SDM-Q-9 immediately after they participate in the high fidelity clinical encounter session.

Secondary outcomes

  1. Acceptability and usability of the tool as measured by an adapted System Usability Scale (SUS)

    The System Usability Scale (SUS) is a short 10-item questionnaire that presents a subjective assessments of usability. The scores are calculated by adjusting odd- and even-numbered item responses, summing the adjusted scores (0-40), and multiplying the total by 2.5 to produce a final score ranging from 0 to 100, where higher scores indicate increased acceptability and usability.

    Time frame: In both simulation 1 and simulation 2, provider participants complete the SUS immediately after they have completed the high fidelity clinical encounter session with a patient participant or a standardized patient.

  2. Acceptability and usability of the tool as measured by Practitioner Opinion Survey

    The Practitioner opinion survey (POS) is a questionnaire that contains 15 items that assess the usability and acceptability of the shared decision-making tool. The total score range is from 15-75, with higher summed score indicating higher usability and acceptability from the perspective of the providers.

    Time frame: In both simulation 1 and simulation 2, provider participants complete the POS immediately after they have completed the high fidelity clinical encounter session with a patient participant or a standardized patient.

07

Study locations

1 of 1 sites recruiting
  • School of Medicine and Public Health, University of Wisconsin
    Madison, Wisconsin 53705, United States
    Recruiting
08

References and documents

Publications

  • Barr PJ, O'Malley AJ, Tsulukidze M, Gionfriddo MR, Montori V, Elwyn G. The psychometric properties of Observer OPTION(5), an observer measure of shared decision making. Patient Educ Couns. 2015 Aug;98(8):970-6. doi: 10.1016/j.pec.2015.04.010. Epub 2015 Apr 29. PubMed 25956069 ↗
  • Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30. PubMed 19879711 ↗
  • Brooke, John. (1995). SUS: A quick and dirty usability scale. Usability Eval. Ind.. 189.

Individual participant data

Plan to share: No — There is currently not a plan to make IPD available.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2026 (actual). Primary completion is estimated for Nov 2027, 13 months after the start.

Of 885 non-industry interventional studies with no phase under Alzheimer Disease, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's planned 13 months is below that.

Counting every sponsor, half of 962 studies reached it within 29 months; a quarter within 15 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 18, 2026
First posted
Sep 10, 2026
StartActual
Oct 7, 2026
Primary completionEst.
Nov 15, 2027
CompletionEst.
Nov 15, 2027
Last update
Oct 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 5, 2026
Sites
School of Medicine and Public Health, University of Wisconsin is now Recruiting
Oct 5, 2026
Start date
Oct 1, 2026→Oct 7, 2026 (actual)
Oct 28, 2026
Show all 2 updates
  1. Oct 28, 2026
    Start date Oct 1, 2026→Oct 7, 2026 (now actual)
  2. Oct 5, 2026
    Not yet recruiting→Recruiting
    School of Medicine and Public Health, University of Wisconsin is now Recruiting

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07812337
Responsible party
Sponsor
First posted
Sep 10, 2026
Start date
Oct 7, 2026
Primary completion
Nov 15, 2027 (estimated)
Completion
Nov 15, 2027 (estimated)
Last update
Oct 28, 2026

Study contacts

Fred Ketchum, M.D., Ph.D.
Contact
BiomarkersInPrimarycare@neurology.wisc.edu
608-265-5523
Fred Ketchum, M.D., Ph.D.
principal investigator · University of Wisconsin, Madison

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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