NCT05922319

Brief Summary

The goal of this observational study is to explore the optimal dose of computerized cognitive training in patients with cognitive impairment. The main questions it aims to answer are:

  • Is there an optimal dose of computerized cognitive training for patients with cognitive impairment?
  • Is the optimal dose different in patients in different age populations? Participants enrolled in the study took a reported computerized cognitive training program and the training data were analyzed for exploring the optimal dose. The researchers will compare the different dose groups to see if there is an optimal dose for the highest improvement in cognitive abilities. The researchers will additionally compare two age groups (aged younger than 60y or aged 60y and older) to see if the optimal doses in the two groups are different.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21,845

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 28, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

May 21, 2024

Status Verified

June 1, 2023

Enrollment Period

2 months

First QC Date

April 2, 2023

Last Update Submit

May 20, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in cognitive abilities between the adjacent weeks

    Cognitive ability is measured on the final day of training each week. The cognitive ability throughout a week is calculated based on the overall performance of cognitive training. The overall training performance is an averaged performance integrating the performance of all cognitive training tasks targeting different cognitive domains (e.g., thinking, memory, perception, attention, executive function). The performance of a certain training task is standardized according to normative scores from 0 to 100. Change in cognitive abilities is quantified as the disparity of cognitive abilities between the adjacent weeks (the measurement will be executed everyweek repeatedly).

    At the end of each week through the study completion (up to 5 years)

Study Arms (1)

Patients with cognitive impairment taking computerized cognitive training

The exposures and outcomes were measured repeatedly during the training process for each patient. The outcomes were compared to assess the effect of different exposures (computerized cognitive training with different doses). A mixed effects model was built to solve the random effects of patients.

Other: Computerized cognitive training with different training doses

Interventions

The training dose was defined as training frequency (number of training days per week) and average training duration per training day. The daily dose was divided into 13 categories with an interval of 5 minutes and the training frequency has 7 categories according to the number of training days per week.

Patients with cognitive impairment taking computerized cognitive training

Eligibility Criteria

Age40 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The participants are outpatients who took a reported computerized cognitive training program at home in 2017-2022 in China.

You may qualify if:

  • Patients with cognitive impairment.
  • Patients who took computerized cognitive training in 2017-2022.
  • age ≥ 40 years
  • Training duration ≥ 2 weeks

You may not qualify if:

  • with moderate to severe dementia, cancer, unstable systemic diseases, or psychiatric diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

Location

MeSH Terms

Conditions

Cognitive DysfunctionDementia

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Yi Tang, M.D., Ph.D.

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2023

First Posted

June 28, 2023

Study Start

July 1, 2023

Primary Completion

August 30, 2023

Study Completion

August 31, 2023

Last Updated

May 21, 2024

Record last verified: 2023-06

Locations