Effects of Individualized Cognitive Training on Cognition in Heart Failure

Study Overview
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Brief Summary
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The SYNAPSE trial is designed to study the effects of an individualized home-based cognitive training program on cognitive functions in heart-failure patients.

Detailed Description
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The purpose of the SYNAPSE study is to evaluate the effects of an individualized home-based training program aimed to improve cognitive functions and well-being in heart failure patients. Heart failure is characterized by the inability of the heart to pump blood efficiently through the body. Nearly half of patients with heart failure present with cognitive deficits. Memory and executive functions that allow us to perform complex tasks are mainly affected. These cognitive deficits are linked to an increased risk of hospitalization and mortality, in addition to decreasing patients' well-being and ability to care for themselves. Although rehabilitation programs that include physical activity and counseling help reduce heart and brain health risks, these programs are unpopular. Among the few who enroll, between 24% and 50% drop out before the completion of the program. Offering alternative options such as cognitive training would help to reach this proportion of patients. The literature has shown that cognitive training is effective in preventing or reducing cognitive deficits in older adults with or without cognitive loss. Although still understudied in patients with heart failure, a better understanding of the association between heart failure and changes in cognition would allow better adaptation of patient care to their situations and needs.

Official Title
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A Multicenter Randomized Single-blinded Clinical Trial to Investigate the Effects of a Home-based Cognitive Training for individualS Affected bY chroNic heArt Failure: an Individualized Program to increaSE Cognitive Functions

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Cognitive training
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult aged 50 or older Have access to Internet Have access to a computer or a tablet; Have the ability to perform cognitive training; Have the ability to read, understand and consent to the informed consent form; Have chronic heart failure on tolerated therapy for at least two months; Without limitation of physical activity to severe limitation of physical activity (i.e. NYHA class I, class II, class III OR class IV). Exclusion Criteria: Acute cardiovascular event 1 month before randomization; Cardiovascular procedure scheduled within 3 months; Uncontrolled diabetes or untreated thyroid dysfunction; Current or recent malignancy with a life expectancy of less than 1 year; Neurological disease; Chronic hemodialysis or peritoneal dialysis.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive training followed by usual care<br>Usual care and cognitive training for 6 weeks, followed by usual care (only) for 6 weeks. | Other: Cognitive training<br>* A cognitive training program will be individually developed for each participant based on baseline neuropsychological tests. It will include: Computerized cognitive training: this training include: the Dual-Task, the Stroop and the N-Back task. The tasks are accompanied by feedback based on the participant's responses (e.g., progress graph, feedback, etc.). In order to promote participants' learning, the level of difficulty of the tasks increased as training sessions progressed. Two sets of stimuli will be used to maximize the generalization of learning. Memory training: This training is adapted from the MEMO+ training program (Belleville et al., 2018). These sessions, also home-based, will be done through online video and are covering a variety of topics: memory (normal aging, mnemonic strategies), attention, aging, etc. Each week, participants will be asked to complete the equivalent of 6 training sessions of 15 minutes each, for a total of 1h30 per week.<br>Other: Usual Care<br>* Participants will be asked to continue the care and follow-up as usually planned with the attending cardiologist. Apart from weekly follow-ups with the research team member, no changes will be made to the participant's medical care.<br>|
| Experimental: Usual care followed by cognitive training<br>Usual care (only) for 6 weeks, followed by cognitive training and usual care for 6 weeks. | Other: Cognitive training<br>* A cognitive training program will be individually developed for each participant based on baseline neuropsychological tests. It will include: Computerized cognitive training: this training include: the Dual-Task, the Stroop and the N-Back task. The tasks are accompanied by feedback based on the participant's responses (e.g., progress graph, feedback, etc.). In order to promote participants' learning, the level of difficulty of the tasks increased as training sessions progressed. Two sets of stimuli will be used to maximize the generalization of learning. Memory training: This training is adapted from the MEMO+ training program (Belleville et al., 2018). These sessions, also home-based, will be done through online video and are covering a variety of topics: memory (normal aging, mnemonic strategies), attention, aging, etc. Each week, participants will be asked to complete the equivalent of 6 training sessions of 15 minutes each, for a total of 1h30 per week.<br>Other: Usual Care<br>* Participants will be asked to continue the care and follow-up as usually planned with the attending cardiologist. Apart from weekly follow-ups with the research team member, no changes will be made to the participant's medical care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in performance on trained computerized cognitive tasks | Trained version of computerized dual-task, modified stroop and n-back tasks Reaction time (ms) | Before and after the 6 weeks of interventions | 
| Changes in performance on trained computerized cognitive tasks | Trained version of computerized dual-task, modified stroop and n-back tasks Accuracy (%) | Before and after the 6 weeks of interventions | 
| Changes in performance on transfer computerized cognitive tasks | Transfer version of computerized dual-task, modified stroop and n-back tasks Reaction time (ms) | Before and after the 6 weeks of interventions | 
| Changes in performance on transfer computerized cognitive tasks | Transfer version of computerized dual-task, modified stroop and n-back tasks Accuracy (%) | Before and after the 6 weeks of interventions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in general cognitive functioning | Remote version of the Montreal Cognitive Assessment. (0-28 score, with a higher score indicating a better cognitive functioning.) | Before and after the 6 weeks of interventions | 
| Changes in performance on neuropsychological tests | Remote version of validated neuropsychological test Memory capacity -Rey Auditory Verbal Learning Test (z-score change) | Before and after the 6 weeks of interventions | 
| Changes in performance on neuropsychological tests | Remote version of validated neuropsychological test Processing speed -Trail making test Part A (z-score change) | Before and after the 6 weeks of interventions | 
| Changes in performance on neuropsychological tests | Remote version of validated neuropsychological test Executive functions Trail making test Part B Verbal fluency test Digit span test (z-score change) | Before and after the 6 weeks of interventions | 
| Change in quality of life | 36-Items Short form health Survey (SF-36) (Score ranges from 0-100, with a higher score indicating more favorable health status.) | Before and after the 6 weeks of interventions | 
| Change in self-care behavior | European Heart-Failure Self-care Behavior Scale-9 (EHFsB-9) (The minimal score is 9 while the maximal score is 45. The higher the score, the less the patient performs self-care behaviors.) | Before and after the 6 weeks of interventions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognition, Heart failure, Individualized cognitive training, Home-based intervention, Remote monitoring