Clinical trial NCT05922319: Effects of Training Dose on Computerized Cognitive Training in Patients With Cognitive Impairment
Official title: Effects of Training Dose on Computerized Cognitive Training in People With Cognitive Impairment: A Large-population Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Impairment, Mild
Dementia
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 21845
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in cognitive abilities between the adjacent weeks
timeFrame: At the end of each week through the study completion (up to 5 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Yi Tang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: