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

NCT05374642 | Completed

• 1 other identifier: 2022-AFFIRMING
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• global cognitive change in 24 weeks

  24 weeks after randomization

• domain cognitive change

  12 weeks, 24 weeks after randomization

• cognitive score change

  12 weeks, 24 weeks after randomization

• self-efficacy scores

  12 weeks, 24 weeks after randomization

• quality of life scores

  12 weeks, 24 weeks after randomization

Study Arms (2)

cognitive training

EXPERIMENTAL

Behavioral: cognitive training

active control

ACTIVE COMPARATOR

Behavioral: active control

Interventions

cognitive training BEHAVIORAL

tablet-based cognitive training for 12 weeks, 30 minutes each time, at least 5 times a week

cognitive training

active control BEHAVIORAL

tablet-based cognitive training tasks with weak or no difficulty changes, 5 times a week, 30 minutes each time for 12 weeks

active control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 18 years;
• Completion of 6 or more years of education;
• Atrial fibrillation confirmed by ECG ;
• Complain of memory decline within 1 year;
• 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;
• Agree to receive cognitive function testing and randomization, be able to receive follow-up as required

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead
• Beijing Wispirit Technology Co., Ltd: collaborator

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (4)

• 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.

  PMID: 24418053 BACKGROUND

• 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.

  PMID: 26389654 BACKGROUND

• 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.

  PMID: 29514809 BACKGROUND

• 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.

  PMID: 29282641 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Atrial Fibrillation

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 16, 2022
• Study Start: September 19, 2022
• Primary Completion: December 22, 2023
• Study Completion: March 27, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

CN (1)