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Behavioural Intervention
Cognitive Training for Heart Failure (SYNAPSE Trial)
N/A
Recruiting
Led By Louis Bherer, PhD
Research Sponsored by Louis Bherer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult aged 50 or older
Without limitation of physical activity to severe limitation of physical activity (i.e. NYHA class I, class II, class III OR class IV)
Must not have
Current or recent malignancy with a life expectancy of less than 1 year
Uncontrolled diabetes or untreated thyroid dysfunction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before and after the 6 weeks of interventions
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the effects of a cognitive training program on heart-failure patients' cognitive functions.
Who is the study for?
This trial is for adults aged 50 or older with chronic heart failure who can use the internet and a computer or tablet. They should be able to do cognitive exercises and understand consent forms. People with severe physical limitations, recent acute cardiovascular events, upcoming heart procedures, uncontrolled diabetes, untreated thyroid issues, short-term cancer prognosis, neurological diseases, or on dialysis cannot join.
What is being tested?
The SYNAPSE trial is testing if a home-based cognitive training program improves thinking skills in patients with heart failure compared to usual care without this program. Participants will either receive the special training or continue their normal routine.
What are the potential side effects?
Since this study involves cognitive exercises rather than medication, traditional side effects are not expected. However, participants may experience fatigue or frustration during mental tasks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 years old or older.
Select...
My heart condition does not severely limit my physical activity.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My life expectancy is less than 1 year due to my current cancer.
Select...
I do not have uncontrolled diabetes or untreated thyroid issues.
Select...
I have a neurological condition.
Select...
I am on long-term dialysis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ before and after the 6 weeks of interventions
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and after the 6 weeks of interventions
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in performance on trained computerized cognitive tasks
Changes in performance on transfer computerized cognitive tasks
Secondary study objectives
Change in general cognitive functioning
Change in quality of life
Change in self-care behavior
+1 moreOther study objectives
Change in Risk of sleep apnea
Change in Walking test speed
Change in anxiety
+10 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Usual care followed by cognitive trainingExperimental Treatment2 Interventions
Usual care (only) for 6 weeks, followed by cognitive training and usual care for 6 weeks.
Group II: Cognitive training followed by usual careExperimental Treatment2 Interventions
Usual care and cognitive training for 6 weeks, followed by usual care (only) for 6 weeks.
Find a Location
Who is running the clinical trial?
Louis BhererLead Sponsor
5 Previous Clinical Trials
377 Total Patients Enrolled
The Montreal Health Innovations Coordinating Center (MHICC)OTHER
13 Previous Clinical Trials
10,832 Total Patients Enrolled
3 Trials studying Heart Failure
482 Patients Enrolled for Heart Failure
Louis Bherer, PhDPrincipal InvestigatorMontreal Heart Institute
8 Previous Clinical Trials
737 Total Patients Enrolled
1 Trials studying Heart Failure
216 Patients Enrolled for Heart Failure