Reducing Cognitive Impairment by Management of Heart Failure as a Modifiable Risk Factor

Study Overview
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Brief Summary
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This study will test the feasibility and effectiveness of an innovative model of care for cognitively impaired patients with heart failure. This program aims to improve cognition, reduce dementia risk and cardiovascular events, and will be supported by innovative digital technology for wide scale rollout and implementation. Findings from this research will transform the way healthcare is delivered to cognitively impaired patients with heart disease who have a very high risk of developing dementia.

Official Title
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Reducing Cognitive Impairment by Management of Heart Failure as a Modifiable Risk Factor: the Cog-HF Trial

Conditions
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Heart Failure, Cognitive Impairment, Dementia, Left Ventricular Dysfunction, Cognitive Change, Cognitive Decline

Intervention / Treatment
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* Other: Disease management program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalised with HF as primary or secondary diagnosis. At least mild cognitive impairment (CI) based on Montreal Cognitive Assessment (MoCA) on hospital discharge. Exclusion Criteria: Unable to provide written consent; requiring palliative care; or participating in another RCT Recovery of cognitive function shortly after hospital discharge: to ensure that we only include patients with true CI, any patients with a repeated MoCA>25 at 2 weeks post-discharge will be excluded. Terminal illness (eg. cancer) that may influence 12-month prognosis.

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Usual care patients will continue with the hospital follow-up plan and routine preventive care after hospital discharge. | |
| Experimental: Intervention<br>Intervention patients will receive a disease management program in addition to the usual care. | Other: Disease management program<br>* The components of our DMP include: Intensive post-discharge education Home surveillance of signs and symptoms will be reviewed (weekly in the first month and monthly thereafter) in a telehealth consultation with patient and/or carer. Medical treatment involves a planned up-titration of cardioprotective medications that will proceed in the absence of advice from the general practitioner (GP) to the contrary. Close observation and frequent appointments are organised by the nurse with the patient's GP during up-titration period. Exercise program delivered by an exercise physiologist Maintenance phase of the DMP: During this maintenance phase, Intervention patients should have been fully transitioned to home care where they are managed by their GP at optimal doses of their medications. Repeated education and exercise guidance will continue with the carer, supported by our cardiac nurse and exercise physiologist via telehealth consultation bimonthly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in MOCA score | Greater Montreal Cognitive Assessment (MOCA) score (ranging 0-30) is better | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiac function | Cardiac function will be measured by echocardiography. Left ventricular global longitudinal strain will be the primary measure of cardiac function. | 12 months | 
| Change in 6-minute walk distance | Functional capacity will be based on 6-minute walk test | 12 and 24 months | 
| Change in quality of life | Quality of life specific to heart failure symptoms will be measured using a disease-specific quality of life questionnaire: Kansas City Cardiomyopathy Questionnaire | 12 and 24 months | 
| Change in MOCA score | Greater Montreal Cognitive Assessment (MOCA) score (ranging 0-30) is better | 24 months | 
| Change in brain volume via MRI measurement |  | 24 months | 
| Change in hand grip strength |  | 12 and 24 months | 
| Change in heart failure classification | Based on New York Heart Association classification | 12 and 24 months |