ClinicalTrials.gg
RecruitingNCT07846566CYOAUpdated Oct 22, 2026

Choose Myself (Before) Losing Myself

An interventional study of CYOA booklet in Dementia (Diagnosis), Mild Cognitive Impairment and Alzheimer's Disease Dementia, sponsored by The Cleveland Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.

Primary conditionAlzheimer DiseaseRegistry: DementiaReclassifiedWhy we changed it
Registry
Dementia — the first condition term the registry derived for this study.
ClinicalTrials.gg
Alzheimer Disease
Why
  1. The study's listed conditions name Alzheimer Disease, a narrower term within Dementia.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Oct 2026; still recruiting 1 month later.
Updated Oct 22, 2026Now RecruitingSite recruiting status changed+2 moreGo to Updates ↓

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

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

Among 1,939 studies in Alzheimer Disease with a site in United States — 345 open to participants now, 445 under way, 40 of them phase 3. Alzheimer Disease · United States.

Planned enrollment
1,208th of 1,608
25 · median 73
Started
2026
with 89 others
No phase
608 of 1,939
130 open now
Primary completion
2027-05
later than 183 of 444 live
Registered
1,932nd of 1,939
by date

Among the 1,939 studies in Alzheimer Disease with a site in United States, this one is the 1,208th largest by planned enrollment of the 1,608 interventional ones that give a count, is one of 90 that started in 2026, is one of 608 with no phase, reaches primary completion later than 183 of the 444 other live ones, and was the 1,932nd 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

345 of the 1,939 studies in Alzheimer Disease with a site in United States are open now. Recruiting first, the newest first:

339 more — sign in →

All 345 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

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: 18 Years and older · all sexes · no healthy volunteers.

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 1,939 studies in Alzheimer Disease with a site in United States, or all of them as a file.
02

Study summary

The purpose of this study is to see if an educational interactive booklet about how dementia progresses throughout a person's life can be a helpful tool for patients to think about future decisions that might need to be made regarding their medical care and helping patients discuss their diagnosis and possible future medical decisions with their family or future caregivers.

03

Conditions studied

  • Dementia (Diagnosis)
  • Mild Cognitive Impairment
  • Alzheimer's Disease Dementia
  • Alzheimer's Disease

Keywords

  • dementia support
  • cognitive impairment
  • memory loss
  • dementia
  • Alzheimer's disease
  • Alzheimer's
  • mild Alzheimer's dementia
04

In context

Alzheimer Disease Reclassified

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

This study's planned enrollment of 25 is below the median of 70 across 3,021 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 832 studies on the registry; 120 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.

Compared within Alzheimer Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dementia. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants are at least 18 years of age
  • Patients including those: newly diagnosed (within 30 days of discussion) and established patients diagnosed with mild cognitive impairment or clinical suspicion of mild Alzheimer's dementia diagnosis based on score (MoCA): 14+, Mini Mental State Exam (MMSE) score: 21+ or Functional Assessment Staging Toll (FAST) score: 1-4
  • Able to read and respond to questions in English (workbook is not available in any other language and survey instruments are validated in English language).

Exclusion criteria

Exclusion Criteria:

  • Individuals who lack decisional capacity
  • Individuals who possess comorbid conditions that, in the opinion of the investigator, would place unnecessary additional burden upon a patient for study participation or patients for whom participation the study would not be in their best interests.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

06

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Other
    The Choose Your Own Adventure Patient Journey with Dementia booklet (CYOA booklet)

    Other: CYOA booklet

Interventions

  • OtherCYOA booklet

    The purpose of the educational booklet in a CYOA format booklet is to provide educational information about the progression of dementia and to help patients to think about potential future medical decisions that may need to be made for them. By being more informed, patients can discuss their wishes with their family members or future caregivers, include preferences in advanced directives, and/or have a discussion with their medical provider about their future care preferences.

07

What researchers measure

Primary outcomes

  1. The Dementia Knowledge Assessment Tool (DKAT2)

    Dementia knowledge will be assessed using the 21-item Dementia Knowledge Assessment Tool Version 2 (DKAT2), which was developed to assess foundation-level knowledge of dementia. Each item has three response options: Yes, No, and Don't Know. Each correct response is assigned 1 point, while an incorrect or Don't Know response is assigned 0 points. Total scores range from 0 to 21, with higher scores indicating greater dementia knowledge. The baseline and follow up assessment may be completed either independently using a paper questionnaire or as an interviewer-administered questionnaire by study personnel. The change in total DKAT2 score from baseline to post-intervention will be assessed.

    Time frame: Participants will complete the DKAT2 at baseline, and 1-30 days after reviewing the toolkit at follow-up telephone encounter. The follow-up assessment window may extend 30 additional days if participants wish to remain in the study.

  2. Patient Education Materials Assessment Tool (PEMAT)

    Patient Education Materials Assessment Tool (PEMAT), will be used to assess understandability and actionability of print educational material. The PEMAT provides two domain scores: understandability and actionability. Understandability is assessed using 17 items, and actionability is assessed using 7 items. Each applicable item is scored as 1 (agree) or 0 (disagree). Domain scores are calculated as the percentage of applicable items receiving a score of 1. Scores range from 0% to 100% for each domain, with higher scores indicating greater understandability and actionability. Understandability and actionability scores will be reported separately. The PEMAT may be completed as an interviewer-administered questionnaire by study personnel.

    Time frame: PEMAT will be completed 1-30 days after reviewing the toolkit at follow-up telephone encounter along with DKAT2. The follow-up assessment window may extend 30 additional days if participants wish to remain in the study.

Other outcomes

  1. Participant-Reported Educational Material Evaluation and Engagement

    There are four open ended questions that will be evaluated to determine thoughts on the toolkit's strengths and areas for improvement. 1. What are the strengths of this educational material? 2. How much of the booklet did you read? 3. Did you find the booklet helpful? (Agree/disagree) 4. What areas about Alzheimer's dementia did you learn about in the educational booklet to foster conversations? These questions will be completed as an interviewer-administered questionnaire by study personnel.

    Time frame: These four questions will be completed 1-30 days after reviewing the toolkit at follow-up telephone encounter along with DKAT2 and PEMAT. The follow-up assessment window may extend 30 additional days if participants wish to remain in the study.

08

Study locations

1 of 1 sites recruiting
09

References and documents

Publications

  • Shoemaker SJ, Wolf MS, Brach C. Development of the Patient Education Materials Assessment Tool (PEMAT): a new measure of understandability and actionability for print and audiovisual patient information. Patient Educ Couns. 2014 Sep;96(3):395-403. doi: 10.1016/j.pec.2014.05.027. Epub 2014 Jun 12. PubMed 24973195 ↗
  • Toye C, Lester L, Popescu A, McInerney F, Andrews S, Robinson AL. Dementia Knowledge Assessment Tool Version Two: development of a tool to inform preparation for care planning and delivery in families and care staff. Dementia (London). 2014 Mar 1;13(2):248-56. doi: 10.1177/1471301212471960. Epub 2013 Jan 16. PubMed 24339059 ↗
  • Kerfoot BP, Kissane N. The use of gamification to boost residents' engagement in simulation training. JAMA Surg. 2014 Nov;149(11):1208-9. doi: 10.1001/jamasurg.2014.1779. No abstract available. PubMed 25229631 ↗
  • Chen PH, Roth H, Galperin-Aizenberg M, Ruutiainen AT, Gefter W, Cook TS. Improving Abnormality Detection on Chest Radiography Using Game-Like Reinforcement Mechanics. Acad Radiol. 2017 Nov;24(11):1428-1435. doi: 10.1016/j.acra.2017.05.005. Epub 2017 Jun 21. PubMed 28647389 ↗
  • Nevin CR, Westfall AO, Rodriguez JM, Dempsey DM, Cherrington A, Roy B, Patel M, Willig JH. Gamification as a tool for enhancing graduate medical education. Postgrad Med J. 2014 Dec;90(1070):685-93. doi: 10.1136/postgradmedj-2013-132486. Epub 2014 Oct 28. PubMed 25352673 ↗
  • Cragun DL, Hunt PP, Dean M, Zierhut H, Kaphingst K, Resnicow K. Creation and beta testing of a "choose your own adventure" digital simulation to reinforce motivational interviewing skills in genetic counseling. J Genet Couns. 2024 Feb;33(1):15-27. doi: 10.1002/jgc4.1833. Epub 2023 Nov 11. PubMed 37950577 ↗
  • Rutledge C, Walsh CM, Swinger N, Auerbach M, Castro D, Dewan M, Khattab M, Rake A, Harwayne-Gidansky I, Raymond TT, Maa T, Chang TP; Quality Cardiopulmonary Resuscitation (QCPR) leaderboard investigators of the International Network for Simulation-based Pediatric Innovation, Research, and Education (INSPIRE). Gamification in Action: Theoretical and Practical Considerations for Medical Educators. Acad Med. 2018 Jul;93(7):1014-1020. doi: 10.1097/ACM.0000000000002183. PubMed 29465450 ↗
  • Deterding S, Dixon D, Khaled R, Nacke L. From game design elements to gamefulness: defining "gamification." In: Proceedings of the 15th International Academic MindTrek Conference: Envisioning Future Media Environments. MindTrek '11. Association for Computing Machinery; 2011:9-15
  • Dementia: a public health priority
  • The Lancet Public Health: Global dementia cases set to triple by 2050 unless countries address risk factors | Institute for Health Metrics and Evaluation
  • Public Health Action in Ohio | Alzheimer's Association. Alzheimer's Association

Individual participant data

Plan to share: No — De-identified data may be shared on a case-by-case basis after compliance and regulatory approval have been obtained. Access will be provided on a case-by-case basis pending approval by the Cleveland Clinic IRB and law department.

10

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 May 2027, 7 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 7 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
Sep 16, 2026
First posted
Sep 29, 2026
StartActual
Oct 9, 2026
Primary completionEst.
May 30, 2027
CompletionEst.
Jul 31, 2027
Last update
Oct 22, 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 22, 2026
Sites
The Cleveland Clinic is now Recruiting
Oct 22, 2026
Start date
Oct 30, 2026→Oct 9, 2026 (actual)
Oct 22, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • The Cleveland Clinic · Cleveland, United StatesContact added r•••@ccf.org · •••9529Contact added G•••@ccf.org · •••8424
Oct 22, 2026
Registered
First appeared on the registry
Sep 29, 2026
Show all 2 updates
  1. Oct 22, 2026
    Not yet recruiting→Recruiting
    The Cleveland Clinic is now Recruiting
    Start date Oct 30, 2026→Oct 9, 2026 (now actual)
    Site contacts Changed at 1 site. See the sites
    Show the site
    • The Cleveland Clinic · Cleveland, United StatesContact added r•••@ccf.org · •••9529Contact added G•••@ccf.org · •••8424
  2. Sep 29, 2026
    First appeared on the registry

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 ↗

11

Registry details

Key details

Study ID
NCT07846566
Responsible party
Kimberlee Fong (Principal Investigator, The Cleveland Clinic) — Principal investigator
First posted
Sep 29, 2026
Start date
Oct 9, 2026
Primary completion
May 30, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Oct 22, 2026

Study contacts

Holly Renner, RN
Contact
rennerh2@ccf.org
2162999529
Toyomi Goto
Contact
GOTOT@ccf.org
216 444-8424
Kimberlee Fong, DO
principal investigator · The Cleveland Clinic

Oversight

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

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