Test-Retest Reliability of DiaMem

NCT07416019 | Not Yet Recruiting

• 1 other identifier: 2026_DiaMem_01
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Memory Functions; Cognition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Test-retest reliability of the MemTrax accuracy score

  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

  6 days (Recorded at each of the 6 assessment sessions)

• Mean DiaMem and MemTrax scores by age group and education level

  At completion of all 6 assessment sessions (Day 6)

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

  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)

Study Arms (2)

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.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥ 60 years, regardless of gender. Willing and able to provide signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 17, 2026
• Study Start: February 14, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL