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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05922319
• Other study ID #: 2023027
• Status: Completed
• Start date: July 1, 2023
• Est. completion date: August 31, 2023

Study information

• Verified date: June 2023
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21845
• Est. completion date: August 31, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment, Mild
• Dementia

Intervention

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.

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)