Test-Retest Reliability of DiaMem

N/ANot Yet RecruitingNCT07416019

Xuanwu Hospital, Beijing30 enrolled

Overview

The goal of this observational study is to learn how reliable the DiaMem memory assessment tool is when used repeatedly over a short period. The main question it aims to answer is: • How consistent are the DiaMem test scores when the same person takes the test multiple times? Researchers will also compare DiaMem with another digital memory test called MemTrax to gather initial information. Participants will: * Be adults aged 60 or older. * Complete a standard memory test and a thinking skills test. * Be randomly split into two groups (A and B). * Take memory tests once a day for 6 days in a row. Group A will take the DiaMem test 3 times first, then the MemTrax test 3 times. Group B will take the tests in the opposite order. • Answer a short questionnaire about how easy the tests were to use.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Memory Functions Cognition

Eligibility

Sex: ALLMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: -Age ≥ 60 years, regardless of gender. Willing and able to provide signed informed consent. Exclusion Criteria: * Corrected visual acuity insufficient to see text/images on a mobile phone screen. * Corrected hearing inability to hear prompts at the phone's maximum volume. Severe upper limb dysfunction (e.g., severe arthritis, Parkinson's tremor) preventing stable phone operation. * Does not own a smartphone, or owns one that cannot properly run WeChat mini-programs. * History of severe mental illness (e.g., major depressive disorder, bipolar disorder, schizophrenia). * History of long-term alcohol or substance abuse. * Hospitalization, emergency visit, or major life event (e.g., myocardial infarction, marriage/divorce, fall) within the past month. * Use of antipsychotics, antidepressants, antiepileptics, sedatives, or plans to use them within the next two weeks. * Planned travel (e.g., inter-city) or other major arrangements likely to interrupt study participation within the next two weeks.

Outcomes

Primary Outcomes

Test-retest reliability of the DiaMem total score

The test-retest reliability (repeatability) of the total score from the DiaMem digital memory assessment tool will be evaluated. Reliability will be quantified using the Intraclass Correlation Coefficient (ICC), calculated from the DiaMem total scores obtained across three test sessions.

Time frame: Days 1 to 3 in Group A and Days 4 to 6 in Group B

Secondary Outcomes

Test-retest reliability of the MemTrax accuracy score

The test-retest reliability of the MemTrax digital memory test will be evaluated using its accuracy score (percentage of correct responses). Reliability will be quantified by the Intraclass Correlation Coefficient (ICC) calculated from the accuracy scores obtained across three test sessions.

Time frame: For Group A, sessions occur on Days 4 to 6; for Group B, on Days 1 to 3.

Actual completion time for the DiaMem and MemTrax assessments

The time (in seconds) taken by participants to complete each assessment session will be recorded separately for the DiaMem and MemTrax tools. The average completion time per tool across all participants and sessions will be calculated and reported as a measure of administrative efficiency.

Time frame: 6 days (Recorded at each of the 6 assessment sessions)

Mean DiaMem and MemTrax scores by age group and education level

The mean total score (for DiaMem) and mean accuracy score (for MemTrax) will be calculated and reported stratified by pre-defined participant subgroups: age groups (60-69, 70-79, ≥80 years) and educational attainment level. This aims to describe the performance distribution of the tools across different demographic segments in the study sample.

Time frame: At completion of all 6 assessment sessions (Day 6)

System Usability Scale (SUS) score for the DiaMem and MemTrax tools

The perceived usability of each digital tool will be assessed using the 10-item System Usability Scale (SUS) questionnaire. Participants will complete the SUS once after their first experience with each tool (i.e., after the first DiaMem session and after the first MemTrax session). The SUS yields a single score ranging from 0 to 100, with higher scores indicating better perceived usability.

Time frame: Assessed once per tool: after the first DiaMem session (Day 1 for Group A / Day 4 for Group B) and after the first MemTrax session (Day 4 for Group A / Day 1 for Group B)