Test-Retest Reliability of DiaMem

An Exploratory Study on the Test-Retest Reliability of the Memory Function Assessment Tool DiaMem

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 Overview

• Status: Not yet recruiting
• Conditions: Cognition; Memory Functions

• Study Type: Observational
• Enrollment (Estimated): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study will enroll a community-based sample of 30 older adults aged 60 years and above. Participants will be stratified by age into three groups (60-69, 70-79, and ≥80 years) to ensure representation across older age ranges. While the primary focus is on validating a measurement tool and not on treating a specific disease, the sample may include individuals with subjective memory complaints or varying cognitive abilities as typically found in a community setting, provided they meet all eligibility criteria.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group A; 3 sessions of DiaMem testing followed by 3 sessions of MemTrax testing.
Group B; 3 sessions of MemTrax testing followed by 3 sessions of DiaMem testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Days 1 to 3 in Group A and Days 4 to 6 in Group B

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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)

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Estimated): February 14, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2026_DiaMem_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Individual participant data (IPD) that will be shared include all study-collected, de-identified individual-level data necessary to reproduce the primary and secondary outcomes reported in future publications. This specifically encompasses:

Participant Baseline Characteristics: Age group, sex, and education level.

Assessment Scores:

For the DiaMem tool: Total score, immediate memory score, and delayed memory score for each of the three sessions.

For the MemTrax tool: Accuracy rate and average response time for each of the three sessions.

Usability Data: System Usability Scale (SUS) score for each tool.

Administrative Data: Actual completion time for each assessment session, and the assigned study group (A or B).

Data will be rigorously de-identified. All direct personal identifiers (e.g., name, contact information, initials, specific birth dates) will be removed. Participants will only be referenced by a unique, anonymized study ID.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No