NCT05735041

Brief Summary

In this study, a multicentre, double-blind, randomized controlled study based on cognitive training was conducted in patients with coronary heart disease and cognitive impairment but without dementia， to evaluate the effectiveness of computer-based digital therapy in improving the cognitive function of such patients.

Trial Health

55
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

8 active sites

Status
active not recruiting

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

Study Start

First participant enrolled

January 18, 2023

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

February 9, 2023

Last Update Submit

February 20, 2024

Conditions

Mild Cognitive ImpairmentCoronary Heart Disease

Keywords

Cognitive trainingDigital therapy

Outcome Measures

Primary Outcomes (1)

  • Global cognitive function change measured by BCAT in 12 weeks

    The proportion of patients whose global cognitive function improves 0.67SD compared to the baseline cognitive function measured by Basic Cognitive Ability test (BCAT). BCAT is a set of neuropsychological battery tests which was designed to measure global cognitive fucntion and cognitive function of sub-domains. Higher scores of BCAT means a better global cognitive function.

    12 weeks after randomization

Secondary Outcomes (7)

  • Global cognitive function change measured by BCAT in 24 weeks

    24 weeks after randomization

  • Sub-domain cognitive function improvement including memory, attention, and execution memory

    12 weeks, 24 weeks after randomization

  • Cognitive score change

    12 weeks, 24 weeks after randomization

  • Self-efficacy score

    12 weeks, 24 weeks after randomization

  • Quality of life score

    12 weeks, 24 weeks after randomization

  • +2 more secondary outcomes

Study Arms (2)

Cognitive digital therapy group

EXPERIMENTAL

Computer-based cognitive training for 30 minutes at least 5 times a week for 12 weeks; At the end of the 12 weeks, the subjects were randomly divided into two groups. One group continued the training for 12 weeks, at least five times a week for 30 minutes each time, and the other group stopped the training.

Behavioral: Multi-domain cognitive digital therapy

Positive control group

ACTIVE COMPARATOR

Computer-based cognitive training tasks with low or no difficulty variation for 30 minutes at least five times a week for 12 weeks

Behavioral: Basic cognitive therapy

Interventions

Multi-domain cognitive digital therapyBEHAVIORAL

Patients in the cognitive digital therapy group received multi-dimensional targeted cognitive function training electronically, involving attention, memory, executive function, thinking, processing speed and perception. The system will adjust the training difficulty and training plan adaptively according to the patient's current training time and performance, and train the patient's weak cognitive ability as far as possible. The patients had the same total amount of training each day.

Cognitive digital therapy group
Basic cognitive therapyBEHAVIORAL

The training content of the positive control group was cognitive training tasks with weak difficulty or no difficulty change. The patients underwent cognitive function training with fixed programs, including 15 training items, and the internal difficulty of the training items remained constant without change. The system presents the training content randomly according to the training scheme. The patients had the same total amount of training each day.

Positive control group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over the age of 50;
  • Completion of more than 6 years of education;
  • Patients with coronary artery disease confirmed by coronary CT angiography or coronary angiography;
  • Chief complaint of cognitive decline within 1 year;
  • The average score of any cognitive domain in processing speed, situational memory, working memory and visual space measured by the Basic Cognitive Ability Test (BCAT) is less than 1 SD compared with the normal population;
  • Agree to be randomized to cognitive function tests and cognitive training and be able to receive follow-up as required.

You may not qualify if:

  • Previous definite diagnosis of dementia or brief Mental State Examination Scale (MMSE) \< 24 points;
  • Cognitive dysfunction caused by cranial trauma, cranial tumor, Parkinson's disease, schizophrenia, Alzheimer's disease, anxiety and depression, and other neuropsychiatric diseases;
  • Deaf and mute or other reasons cannot communicate normally;
  • Binge drinking or taking drugs (antihistamines, antipsychotics) that affect cognitive function;
  • Unable to master the use of cognitive training equipment after two 1-hour training instructions each time;
  • Patients who plan to undergo coronary intervention within 6 months or have undergone coronary intervention within 1 month;
  • Severe liver and kidney function injury or critical condition, poor prognosis, estimated survival of less than 1 month.
  • Patients who had received general anesthesia within 3 months;
  • History of stroke and craniocerebral trauma within 6 months;
  • History of Parkinson's disease, schizophrenia, and epilepsy;
  • Prior neurosurgery or history of cranial tumors;
  • Nuclear magnetic examination contraindications: such as metal implants, claustrophobia, etc.;
  • patients living alone;
  • Patients with atrial fibrillation, structural heart disease, and infective endocarditis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Beijing Anzhen Hospital

Beijing, China

Location

Beijing Sixth Hospital

Beijing, China

Location

Peking University Third Hospital

Beijing, China

Location

The second hospital of Chifeng

Chifeng, China

Location

Handan Central Hospital

Handan, China

Location

Inner Mongolia Ordos Central Hospital Kangbashi Department

Ordos, China

Location

The First Affiliated Hospital of Hebei North University

Shijiazhuang, China

Location

The First Hospital of Hebei Medical University

Zhangjiakou, China

Location

Related Publications (1)

  • Ye Y, Chen Q, Li R, Wang X, Sun Y, Li F, Liu X, Wang L, Ning X, Tian H, Zhao W, Ma C, Zhang H, Zeng Y. The efficacy of computerized cognitive training in patients with coronary heart disease and cognitive impairment, no dementia: study protocol for a randomized controlled trial. Trials. 2025 Feb 21;26(1):64. doi: 10.1186/s13063-025-08745-6.

    PMID: 39985041DERIVED

MeSH Terms

Conditions

Cognitive DysfunctionCoronary Disease

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 9, 2023

First Posted

February 21, 2023

Study Start

January 18, 2023

Primary Completion

December 31, 2024

Study Completion

July 31, 2025

Last Updated

February 21, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(8)