CClinicalTrials.gg
Not yet recruitingNCT07846566CYOAUpdated Sep 29, 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. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

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

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

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.

02

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
03

Who can participate

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

Inclusion criteria

  • 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).

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.
04

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.

05

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.

06

Study locations

1 site
  • The Cleveland Clinic
    Cleveland, Ohio 44195, United States
07

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.

08

Registry details

Key details

Study ID
NCT07846566
Lead sponsor
The Cleveland Clinic
Responsible party
Kimberlee Fong (Principal Investigator, The Cleveland Clinic) — Principal investigator
First posted
Sep 29, 2026
Start date
Oct 30, 2026 (estimated)
Primary completion
May 30, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Sep 29, 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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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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