AzTrials
AzTrials

Dementia (Diagnosis)CYOANCT07846566

Choose Myself (Before) Losing Myself

A study testing CYOA booklet in people with Dementia (Diagnosis) and Mild Cognitive Impairment, run by The Cleveland Clinic at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CYOA booklet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
9 Oct 2026to 31 Jul 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants are at least 18 years of age
  • Patients including those: newly diagnosed (within 30 days of informed consent discussion) and established patients diagnosed with mild cognitive impairment or clinical suspicion of mild Alzheimer's dementia diagnosis based on Montreal Cognitive Assessment 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Holly Renner, RN contact

2162999529

rennerh2@ccf.org

Toyomi Goto contact

216 444-8424

GOTOT@ccf.org

United States1 site, 1 recruiting

  • The Cleveland Clinic

    Cleveland, Ohio, 44195

    Holly Renner, RN, 216-299-9529, rennerh2@ccf.org

    Toyomi Goto, MS, 216 444-8424, GOTOT@ccf.org

    Recruiting

Other trials in United States

About this study

Official title: Choose Myself (Before) Losing Myself: Providing Educational Information to Empower Alzheimer's Dementia Patients and Their Caregivers Utilizing Gamification Techniques Such as Choose Your Own Adventure.

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.

Being tested
CYOA booklet
Keywords
dementia support, cognitive impairment, memory loss, dementia, Alzheimer's disease, Alzheimer's, mild Alzheimer's dementia
Medical subject headings
Dementia, Disease, Cognitive Dysfunction, Alzheimer Disease, Memory Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CYOA bookletOther

    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.

Study groups in NCT07846566
Study groupRoleWhat they receive
The Choose Your Own Adventure Patient Journey with Dementia booklet (CYOA booklet)OtherNot described
Receives: Other: CYOA booklet

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2026
  2. Study start9 Oct 2026
  3. Primary completion30 May 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07846566
Sponsor's protocol ID
26-158
Other IDs
CCG0339
Acronym
CYOA
Status last verified
Sep 2026
First submitted
16 Sep 2026
Last updated
22 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

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

Questions about this trial

What is this clinical trial studying?

A study testing CYOA booklet in people with Dementia (Diagnosis) and Mild Cognitive Impairment, 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 22 Oct 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?

Contact Holly Renner, RN (2162999529, rennerh2@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Dementia Knowledge Assessment Tool (DKAT2) (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07846566, which also lists 11 linked publications.

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 22 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in