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Not yet recruiting NCT07416019

Test-Retest Reliability of DiaMem

Observational Memory Functions Cognition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Memory Functions, Cognition. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

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.

Primary outcome measures

  • Test-retest reliability of the DiaMem total score [Time frame: Days 1 to 3 in Group A and Days 4 to 6 in Group B]
Secondary outcome measures (4)
  • Test-retest reliability of the MemTrax accuracy score [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 [Time frame: 6 days (Recorded at each of the 6 assessment sessions)]
  • Mean DiaMem and MemTrax scores by age group and education level [Time frame: At completion of all 6 assessment sessions (Day 6)]
  • System Usability Scale (SUS) score for the DiaMem and MemTrax tools [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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07416019 · 2026_DiaMem_01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗