Heart Failure
Conditions
Keywords
Heart failure, Cognition, Individualized cognitive training, Home-based intervention, Remote monitoring
Brief summary
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
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.
Interventions
OTHERCognitive training
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.
OTHERUsual Care
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.
Sponsors
The Montreal Health Innovations Coordinating Center (MHICC)
Louis Bherer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Single blind masking: the research personnel performing the outcome assessments at baseline, between the intervention (two months) and after the intervention (four months) will be blinded to groups' intervention order. Participants will be aware of the order in which they receive the intervention.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in performance on trained computerized cognitive tasks | Before and after the 6 weeks of interventions | Trained version of computerized dual-task, modified stroop and n-back tasks Reaction time (ms) |
| Changes in performance on transfer computerized cognitive tasks | Before and after the 6 weeks of interventions | Transfer version of computerized dual-task, modified stroop and n-back tasks Reaction time (ms) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in general cognitive functioning | Before and after the 6 weeks of interventions | Remote version of the Montreal Cognitive Assessment. (0-28 score, with a higher score indicating a better cognitive functioning.) |
| Changes in performance on neuropsychological tests | Before and after the 6 weeks of interventions | Remote version of validated neuropsychological test Memory capacity -Rey Auditory Verbal Learning Test (z-score change) |
| Change in quality of life | Before and after the 6 weeks of interventions | 36-Items Short form health Survey (SF-36) (Score ranges from 0-100, with a higher score indicating more favorable health status.) |
| Change in self-care behavior | Before and after the 6 weeks of interventions | 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.) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Walking test speed | Before and after the 6 weeks of interventions | 4-meter walking test (m/s) |
| Change in functional mobility | Before and after the 6 weeks of interventions | Timed up and Go test (s) |
| Change in balance performance | Before and after the 6 weeks of interventions | Timed one-leg standing test (s) |
| Change in depressive symptomatology | Before and after the 6 weeks of interventions | Patient Health Questionnaire (PHQ-9) (Score ranges from 0 to 27, with a higher score indicating a more severe depression state.) |
| Cognitive Reserve | Baseline | Rami and colleagues' cognitive reserve questionnaire (Scale ranges from 0-26, with a higher score indicating a greater cognitive reserve) |
| Self-reported masculinity and femininity traits | Baseline | Short Form BEM Sex-Role Inventory questionnaire (30 items questionnaire with 10 items assessing the femininity traits, 10 items assessing the masculinity traits and 10 items neutral, not scored. Two scores, rage from 10-70, are calculated for femininity and masculinity, respectively. A higher score is indicating a higher trait.) |
| Dietary patterns | Baseline | Short Diet Questionnaire (Score ranges from 15-45 points, with a score between 15-29 categorized as unhealthy, 30-37 as somewhat unhealthy and 38 or more as a healthy diet.) |
| Change in lower limb muscles strength | Before and after the 6 weeks of interventions | Timed Sit-to-Stand test (s) |
| Change in anxiety | Before and after the 6 weeks of interventions | General Anxiety Disorder questionnaire (GAD-7) (Total score ranges from 0 to 21, with an increasing score on the scale is indicating a worse anxiety state.) |
| Change in perceived stress | Before and after the 6 weeks of interventions | Perceived Stress Scale questionnaire (PSS-10) (Score ranges from 0-40, with a higher score indicating a worse sleep quality) |
| Change in quality of sleep | Before and after the 6 weeks of interventions | Pittsburgh Sleep Quality Index questionnaire (PSQI) (19 self-assessment questions are grouped into seven components. The scores for the seven components are summed to give an overall score that ranges from 0 to 21 points, with 0 indicating no difficulty and 21 indicating severe difficulty in all components. A score higher than 5 indicates problematic sleep in one or more components) |
| Change in Risk of sleep apnea | Before and after the 6 weeks of interventions | Berlin Questionnaire (Participants are classified into a high or a low risk of sleep apnea based their responses to the individual items and their overall scores in the symptom categories. A High Risk represent 2 or more categories where the score is positive. A low risk represents 1 or no category where the score is positive.) |
| Change in self-reported physical activity | Before and after the 6 weeks of interventions | Physical Activity Scale for the Elderly Questionnaire (PASE) (The overall score ranges from 0 to 400, with a higher score indicating a better level of physical activity) |
Countries
Canada
Contacts
Primary ContactLouis Bherer, PhD
Backup ContactCaroll-Ann Blanchette, MSc
Outcome results
None listed