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临床试验/NCT07846566
NCT07846566尚未招募不适用

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 Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2026年10月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
25
试验地点
1
主要终点
The Dementia Knowledge Assessment Tool (DKAT2)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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).

排除标准

  • •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.

研究组 & 干预措施

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

Other

干预措施: CYOA booklet (Other)

结局指标

主要结局

The Dementia Knowledge Assessment Tool (DKAT2)

时间窗: 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.

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.

Patient Education Materials Assessment Tool (PEMAT)

时间窗: 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.

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kimberlee Fong

Principal Investigator

The Cleveland Clinic

研究点 (1)

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