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Computerized Cognitive Training in Patients With Coronary Heart Disease and Mild Cognitive Impairment (COG-T CHD)

Primary Purpose

Mild Cognitive Impairment, Coronary Heart Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Multi-domain cognitive digital therapy
Basic cognitive therapy
Sponsored by
Beijing Anzhen Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Cognitive training, Digital therapy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Beijing Anzhen HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive digital therapy group

Positive control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Global cognitive function change measured by BCAT in 24 weeks
The proportion of patients whose global cognitive function improves 0.67SD compared to the baseline cognitive function at 24 weeks measured by Basic cognitive Ability Test(BCAT).
Sub-domain cognitive function improvement including memory, attention, and execution memory
The proportion of patients whose sub-domain cognitive function, including attention, memory, execution function improves measured by the individual capability test in BCAT.
Cognitive score change
Mean change from baseline in global cognitive function score measured by basic cognitive ability test (BCAT) at 12 weeks and 24 weeks.
Self-efficacy score
Mean change from baseline in self-efficacy score measured by the General Self-Efficacy Scale at 12 weeks, and 24 weeks
Quality of life score
Mean change from baseline in the patient's quality of life score measured by EQ-5D-3L at 12 weeks and 24 weeks.
Anxiety score
Mean change from baseline in the patient's anxiety score at 12 weeks and 24 weeks. Anxiety status will be measured by GAD-7 questionnaire. Higher score of GAD-7 scale represents more anxiety status.
Depression score
Mean change from baseline in the patient's depression score at 12 weeks and 24 weeks. Depression status will be measured by PHQ-9 questionnaire. Higher score of PHQ-9 scale represents more depression status.

Full Information

First Posted
February 9, 2023
Last Updated
February 9, 2023
Sponsor
Beijing Anzhen Hospital
Collaborators
Beijing Wispirit Technology Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05735041
Brief Title
Computerized Cognitive Training in Patients With Coronary Heart Disease and Mild Cognitive Impairment
Acronym
COG-T CHD
Official Title
The Efficacy of Computerized Cognitive Training in Patients With Coronary Heart Disease and Cognitive Impairment, no Dementia: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Anzhen Hospital
Collaborators
Beijing Wispirit Technology Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study, a 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.
Detailed Description
This study is a double-blinded, randomized controlled trial. A total of 200 CHD patients with mild cognitive impairment will be recruited after the screening. These patients will be randomized to two arms under masking. The intervention arm will receive multi-domain adaptive cognitive training using a tablet. The control arm will receive an active control treatment and use the same tablet to receive the cognitive training tasks with weak difficulty change. Both arms will receive the same intervention dosage for 12 weeks, 5 times a week, and 30 minutes per time. After the 12-week intervention, the intervention arm will be re-randomized into two groups. One group will stop their intervention at 12 weeks; the other group will continue to receive the multi-domain adaptive cognitive training till the 24-week follow-up assessment. The neuro-psychological assessment will be administered at baseline, 12-week, and 24-week assessments for all participants. The structural and functional MRI will be administered at baseline, 12 weeks, and 24 weeks to evaluate the effect of cognitive training on brain structure and function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Coronary Heart Disease
Keywords
Cognitive training, Digital therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive digital therapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
Positive control group
Arm Type
Active Comparator
Arm Description
Computer-based cognitive training tasks with low or no difficulty variation for 30 minutes at least five times a week for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Multi-domain cognitive digital therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Basic cognitive therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Global cognitive function change measured by BCAT in 12 weeks
Description
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.
Time Frame
12 weeks after randomization
Secondary Outcome Measure Information:
Title
Global cognitive function change measured by BCAT in 24 weeks
Description
The proportion of patients whose global cognitive function improves 0.67SD compared to the baseline cognitive function at 24 weeks measured by Basic cognitive Ability Test(BCAT).
Time Frame
24 weeks after randomization
Title
Sub-domain cognitive function improvement including memory, attention, and execution memory
Description
The proportion of patients whose sub-domain cognitive function, including attention, memory, execution function improves measured by the individual capability test in BCAT.
Time Frame
12 weeks, 24 weeks after randomization
Title
Cognitive score change
Description
Mean change from baseline in global cognitive function score measured by basic cognitive ability test (BCAT) at 12 weeks and 24 weeks.
Time Frame
12 weeks, 24 weeks after randomization
Title
Self-efficacy score
Description
Mean change from baseline in self-efficacy score measured by the General Self-Efficacy Scale at 12 weeks, and 24 weeks
Time Frame
12 weeks, 24 weeks after randomization
Title
Quality of life score
Description
Mean change from baseline in the patient's quality of life score measured by EQ-5D-3L at 12 weeks and 24 weeks.
Time Frame
12 weeks, 24 weeks after randomization
Title
Anxiety score
Description
Mean change from baseline in the patient's anxiety score at 12 weeks and 24 weeks. Anxiety status will be measured by GAD-7 questionnaire. Higher score of GAD-7 scale represents more anxiety status.
Time Frame
12 weeks, 24 weeks after randomization
Title
Depression score
Description
Mean change from baseline in the patient's depression score at 12 weeks and 24 weeks. Depression status will be measured by PHQ-9 questionnaire. Higher score of PHQ-9 scale represents more depression status.
Time Frame
12 weeks, 24 weeks after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Zeng, PhD
Phone
13501373114
Email
13501373114@163.com
Facility Information:
Facility Name
Beijing Anzhen Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Zeng
Email
13501373114@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Computerized Cognitive Training in Patients With Coronary Heart Disease and Mild Cognitive Impairment

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