Recruiting

Observational Study

Sponsor:

The Cleveland Clinic

Code:

NCT07846566

Conditions

Dementia (Diagnosis)

Mild Cognitive Impairment

Alzheimer's Disease Dementia

Alzheimer's Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CYOA booklet

Study Details

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)

Mild Cognitive Impairment

Alzheimer's Disease Dementia

Alzheimer's Disease

Study ID

NCT07846566

Start date

Oct 9, 2026

Status verified date

Sep, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

May 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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:

  • 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.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

Interventions

CYOA 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.

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. ]
  • Patient Education Materials Assessment Tool (PEMAT) [ 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. ]

Central Contacts and Locations

Central contacts

Holly Renner, RN

2162999529rennerh2@ccf.org

Toyomi Goto

216 444-8424GOTOT@ccf.org

Locations

The Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Holly Renner, RN

216-299-9529rennerh2@ccf.org

Toyomi Goto, MS

216 444-8424GOTOT@ccf.org

More Information

Sponsor

The Cleveland Clinic

Last update posted

Oct 22, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.