Atrial Fibrillation Follow-up Investigation to Recover Memory and learnING Trial

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Cognitive Impairment
• Interventions: Behavioral: cognitive training; Behavioral: active control

• Registration Number: NCT05374642
• Lead Sponsor: Beijing Anzhen Hospital

Brief Summary

The objective of the study is to evaluate the effectiveness of cognitive training in people with atrial fibrillation and cognitive decline over 12-week cognitive training. Moreover, the investigators will explore whether the training effect can be maintained.

Detailed Description

Introduction: Cognitive impairment is a clinical condition characterized of a reduction in memory and/or other cognitive processes that are insufficiently severe to be diagnosed as dementia.The prevalence of dementia among people over 65 years old in China is 5.14% , while the prevalence of mild cognitive impairment is 20.8%. The risk of cognitive impairment and dementia in patients with atrial fibrillation is significantly higher than that those in the same age group, even after adjusted stroke and other common risk factors such as hypertension and diabetes. At present, the effectiveness of cognitive training in patients with atrial fibrillation complicated with cognitive impairment is not clear.

Objectives: The objective of the study is to evaluate whether cognitive training could lead cognitive improvement in patients with cognitive impairment and atrial fibrillation.

Patients and Methods: The proposed study is a double blinded, randomized and controlled trial that will include 200 patients with cognitive impairment and atrial fibrillation. The groups will be randomized to either intervention or active-control group. Both groups will receive computerized cognitive training performed for 30 minutes x 5 times/week over 12 weeks. A neuropsychological assessment will be administered at baseline and week 12 and 24 after the intervention. The structural and functional MRI will be performed at baseline and week 12 after intervention for a sub-study on the effect of cognitive training on brain structure and function.

Study Timeline

• Study First Submitted: 2022-05-10
• Study First Submitted QC: 2022-05-13
• Study First Posted: 2022-05-16
• Study Start: 2022-09-19
• Primary Completion: 2023-12-22
• Study Completion: 2024-03-27
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Older than 18 years;
2. Completion of 6 or more years of education;
3. Atrial fibrillation confirmed by ECG ;
4. Complain of memory decline within 1 year;
5. The score of any cognitive domain in the processing speed, episodic memory, working memory, and visual-spatial tested by the Basic Cognitive Ability Assessment (BCAT) is 1SD less than the average of the normal population;
6. Agree to receive cognitive function testing and randomization, be able to receive follow-up as required

Exclusion Criteria

1. Unable to complete the test due to vision, hearing and other problems;
2. Dementia or MMSE Scale ≤ 20;
3. Alcohol abuse or taking drugs that affect cognitive function (antihistamines, antipsychotics);
4. Cannot master the method of cognitive training tool after 2 times, 1 hour each time training instruction;
5. Planned atrial fibrillation ablation within 3 months or received ablation in the last 3 months;
6. CHA2DS2-VASc score ≥ 2 (for female ≥ 3), but refuses anticoagulation or has anticoagulation contraindications;
7. General anaesthesia in the last 3 months;
8. A history of stroke and head injury in the last 6 months;
9. Past history of Parkinson's disease, schizophrenia, and epilepsy;
10. Previous neurosurgery or a history of head tumor;
11. Contraindications for MRI examination: such as metal implantation, claustrophobia, etc.;
12. No family members to assist the patients to do the training course

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cognitive training	cognitive training	-
active control	active control	-

Primary Outcome Measures

Name	Time	Method
global cognitive change in 12 weeks	12 weeks after randomization	The percentage of patients whose global cognitive function measured at 12 weeks after intervention improves 0.67 SD compared to that measured at baseline by basic cognitive ability test (BCAT)

Secondary Outcome Measures

Name	Time	Method
global cognitive change in 24 weeks	24 weeks after randomization	The percentage of patients whose global cognitive function improved at 24 weeks
domain cognitive change	12 weeks, 24 weeks after randomization	The percentage of patients whose cognitive function improved in any domain at 12 weeks and at 24 weeks;
quality of life scores	12 weeks, 24 weeks after randomization	Changes in the patient's quality of life scores compared with baseline at 12 weeks and at 24 weeks. quality of life will be measured using EQ-5D-3L(EuroQol 5-Dimensional 3 level version).
cognitive score change	12 weeks, 24 weeks after randomization	Changes in global cognitive function scores at 12 weeks and at 24 weeks
self-efficacy scores	12 weeks, 24 weeks after randomization	Changes in the patient's self-efficacy scores compared with baseline at 12 weeks and at 24 weeks. The General Self-Efficacy scale ranged from 10 to 40, and higher scores mean better self-efficacy.
anxiety and depression scores	12 weeks, 24 weeks after randomization	Changes in the patient's anxiety and depression scores compared with baseline at 12 weeks and at 24 weeks. Anxiety status will be measured using the GAD-7 questionnaire which ranges from 0 to 21, with a higher score representing more anxiety. Depression status will be measured using the PHQ-9 questionnaire which ranges from 0 to 27, with a higher score representing more depression.

Trial Locations

Locations (1)

Beijing Anzhen Hospital; 🇨🇳 Beijing, Beijing, China