Choose Myself (Before) Losing Myself

NCT07846566 | Not Yet Recruiting

• 2 other identifiers: 26-158CCG0339
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

dementia support; cognitive impairment; memory loss; dementia; Alzheimer's disease; Alzheimer's; mild Alzheimer's dementia

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

• 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.

  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

  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.

Study Arms (1)

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

OTHER

Other: CYOA booklet

Interventions

CYOA booklet OTHER

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (11)

• 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.

  PMID: 24973195 BACKGROUND

• 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.

  PMID: 24339059 BACKGROUND

• 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.

  PMID: 25229631 BACKGROUND

• 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.

  PMID: 28647389 BACKGROUND

• 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.

  PMID: 25352673 BACKGROUND

• 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.

  PMID: 37950577 BACKGROUND

• 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.

  PMID: 29465450 BACKGROUND

• 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

  BACKGROUND

• Dementia: a public health priority

  BACKGROUND

• The Lancet Public Health: Global dementia cases set to triple by 2050 unless countries address risk factors | Institute for Health Metrics and Evaluation

  BACKGROUND

• Public Health Action in Ohio | Alzheimer's Association. Alzheimer's Association

  BACKGROUND

MeSH Terms

Conditions

Dementia; Disease; Cognitive Dysfunction; Alzheimer Disease; Memory Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Tauopathies; Neurodegenerative Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Kimberlee Fong, DO

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Holly Renner, RN

CONTACT

2162999529; rennerh2@ccf.org

Toyomi Goto

CONTACT

216 444-8424; GOTOT@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 29, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)