Effects of Training Dose on Computerized Cognitive Training in Patients With Cognitive Impairment

Effects of Training Dose on Computerized Cognitive Training in People With Cognitive Impairment: A Large-population Retrospective Study

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Cognitive Impairment, Mild
• Intervention / Treatment: Other: Computerized cognitive training with different training doses

Detailed Description

Background: Computerized Cognitive Training (CCT) is a form of digital therapeutics that uses computerized cognitive tasks to train patients with cognitive impairment caused by various neurological or psychiatric diseases. CCT has been shown to slow the progression of cognitive impairment in early-stage dementia, particularly in working memory. However, there is a lack of research on the optimal training dose for people with cognitive impairment. Previous meta-analyses have explored the types, delivery methods, and training dose of cognitive training in healthy older adults and those with dementia risk factors, but not in those with cognitive impairment.

Objectives: The study aimed to explore the dose-response relationship of CCT and estimate the optimal daily and weekly dose for people with cognitive impairment.

Participants and methods: the study is a retrospective cohort study and will enroll 21845 patients with cognitive impairment. The exposures in the study are different doses of cognitive training in a week and the outcome is the improvement in cognitive abilities in a week. The weeks with the same training dose of different patients will be classified into one group of exposure. The mixed effects model will be used to estimate the optimal dose.

• Study Type: Observational
• Enrollment (Actual): 21845

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100053
    • Xuanwu Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Investigators: Principal Investigator: Yi Tang, M.D., Ph.D., Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: April 2, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 2023027 (Other Identifier: Helse Sor-Ost (Helse Sør-Øst))

Drug and device information, study documents

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