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

Randomized Controlled Trial of Computerized Cognitive Training in Patients With Atrial Fibrillation With Cognitive Impairment But Without Dementia

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Impairment; Atrial Fibrillation
• Intervention / Treatment: Behavioral: cognitive training; Behavioral: active control

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Beijing Anzhen Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cognitive training	Behavioral: cognitive training; tablet-based cognitive training for 12 weeks, 30 minutes each time, at least 5 times a week
Active Comparator: active control	Behavioral: active control; tablet-based cognitive training tasks with weak or no difficulty changes, 5 times a week, 30 minutes each time for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
global cognitive change in 12 weeks	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)	12 weeks after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
global cognitive change in 24 weeks	The percentage of patients whose global cognitive function improved at 24 weeks	24 weeks after randomization
domain cognitive change	The percentage of patients whose cognitive function improved in any domain at 12 weeks and at 24 weeks;	12 weeks, 24 weeks after randomization
cognitive score change	Changes in global cognitive function scores at 12 weeks and at 24 weeks	12 weeks, 24 weeks after randomization
self-efficacy scores	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.	12 weeks, 24 weeks after randomization
quality of life scores	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).	12 weeks, 24 weeks after randomization
anxiety and depression scores	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.	12 weeks, 24 weeks after randomization

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Collaborators: Beijing Wispirit Technology Co., Ltd

Publications and helpful links

General Publications

• Jia J, Zhou A, Wei C, Jia X, Wang F, Li F, Wu X, Mok V, Gauthier S, Tang M, Chu L, Zhou Y, Zhou C, Cui Y, Wang Q, Wang W, Yin P, Hu N, Zuo X, Song H, Qin W, Wu L, Li D, Jia L, Song J, Han Y, Xing Y, Yang P, Li Y, Qiao Y, Tang Y, Lv J, Dong X. The prevalence of mild cognitive impairment and its etiological subtypes in elderly Chinese. Alzheimers Dement. 2014 Jul;10(4):439-447. doi: 10.1016/j.jalz.2013.09.008. Epub 2014 Jan 10.
• de Bruijn RF, Heeringa J, Wolters FJ, Franco OH, Stricker BH, Hofman A, Koudstaal PJ, Ikram MA. Association Between Atrial Fibrillation and Dementia in the General Population. JAMA Neurol. 2015 Nov;72(11):1288-94. doi: 10.1001/jamaneurol.2015.2161.
• Chen LY, Norby FL, Gottesman RF, Mosley TH, Soliman EZ, Agarwal SK, Loehr LR, Folsom AR, Coresh J, Alonso A. Association of Atrial Fibrillation With Cognitive Decline and Dementia Over 20 Years: The ARIC-NCS (Atherosclerosis Risk in Communities Neurocognitive Study). J Am Heart Assoc. 2018 Mar 7;7(6):e007301. doi: 10.1161/JAHA.117.007301.
• Sherman DS, Mauser J, Nuno M, Sherzai D. The Efficacy of Cognitive Intervention in Mild Cognitive Impairment (MCI): a Meta-Analysis of Outcomes on Neuropsychological Measures. Neuropsychol Rev. 2017 Dec;27(4):440-484. doi: 10.1007/s11065-017-9363-3. Epub 2017 Dec 27.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2022
• Primary Completion (Actual): December 22, 2023
• Study Completion (Actual): March 27, 2024

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: May 13, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Arrhythmias, Cardiac; Cognition Disorders; Atrial Fibrillation; Cognitive Dysfunction
• Other Study ID Numbers: 2022-AFFIRMING

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No