Cognitive Change, Cognitive Decline, Cognitive Impairment, Dementia, Heart Failure, Left Ventricular Dysfunction
Conditions
Brief summary
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.
Interventions
The components of our DMP include: 1. Intensive post-discharge education 2. 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. 3. 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. 4. Exercise program delivered by an exercise physiologist 5. 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.
Sponsors
Baker Heart and Diabetes Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Hospitalised with HF as primary or secondary diagnosis. 2. At least mild cognitive impairment (CI) based on Montreal Cognitive Assessment (MoCA) on hospital discharge.
Exclusion criteria
1. Unable to provide written consent; requiring palliative care; or participating in another RCT 2. 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. 3. Terminal illness (eg. cancer) that may influence 12-month prognosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in MOCA score | 12 months | Greater Montreal Cognitive Assessment (MOCA) score (ranging 0-30) is better |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in hand grip strength | 12 and 24 months | — |
| Change in heart failure classification | 12 and 24 months | Based on New York Heart Association classification |
| Change in cardiac function | 12 months | Cardiac function will be measured by echocardiography. Left ventricular global longitudinal strain will be the primary measure of cardiac function. |
| Change in brain volume via MRI measurement | 24 months | — |
| Change in quality of life | 12 and 24 months | Quality of life specific to heart failure symptoms will be measured using a disease-specific quality of life questionnaire: Kansas City Cardiomyopathy Questionnaire |
| Change in MOCA score | 24 months | Greater Montreal Cognitive Assessment (MOCA) score (ranging 0-30) is better |
| Change in 6-minute walk distance | 12 and 24 months | Functional capacity will be based on 6-minute walk test |
Countries
Australia
Contacts
Primary ContactQuan Huynh
Outcome results
None listed