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Cognitive ImpairmentAFFIRMINGNCT05374642

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

A study testing cognitive training in people with Cognitive Impairment and Atrial Fibrillation, run by Beijing Anzhen Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cognitive Impairment, Atrial Fibrillation
What is being tested?
cognitive training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
19 Sep 2022to 27 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Anzhen Hospital

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
cognitive training, active control
Medical subject headings
Cognitive Dysfunction, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cognitive trainingBehavioural

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

  • active controlBehavioural

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

Study groups in NCT05374642
Study groupRoleWhat they receive
cognitive trainingExperimentalNot described
Receives: Behavioral: cognitive training
active controlActive comparatorNot described
Receives: Behavioral: active control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 12 weeks after randomization

Secondary outcomes (6)

  1. global cognitive change in 24 weeks

    The percentage of patients whose global cognitive function improved at 24 weeks

    Measured: 24 weeks after randomization

  2. domain cognitive change

    The percentage of patients whose cognitive function improved in any domain at 12 weeks and at 24 weeks;

    Measured: 12 weeks, 24 weeks after randomization

  3. cognitive score change

    Changes in global cognitive function scores at 12 weeks and at 24 weeks

    Measured: 12 weeks, 24 weeks after randomization

  4. 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.

    Measured: 12 weeks, 24 weeks after randomization

  5. 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).

    Measured: 12 weeks, 24 weeks after randomization

  6. 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.

    Measured: 12 weeks, 24 weeks after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2022
  2. Study start19 Sep 2022
  3. Primary completion22 Dec 2023
  4. Study completion27 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05374642
Sponsor's protocol ID
2022-AFFIRMING
Acronym
AFFIRMING
Status last verified
May 2024
First submitted
10 May 2022
Last updated
24 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 24418053

  • 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.

    PubMed 26389654

  • 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.

    PubMed 29514809

  • 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.

    PubMed 29282641

Questions about this trial

What is this clinical trial studying?

A study testing cognitive training in people with Cognitive Impairment and Atrial Fibrillation, run by Beijing Anzhen Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

global cognitive change in 12 weeks (time frame: 12 weeks after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05374642, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.

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