An interventional study of Disease management program in Heart Failure, Cognitive Impairment and Dementia, sponsored by Baker Heart and Diabetes Institute. Recruiting at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-12.
Sponsored by Baker Heart and Diabetes Institute · Not applicable, Interventional, and Prevention
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 168 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Baker Heart and Diabetes Institute is the lead sponsor of 26 studies on the registry; 8 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Usual care patients will continue with the hospital follow-up plan and routine preventive care after hospital discharge.
Intervention patients will receive a disease management program in addition to the usual care.
Other: Disease management program
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.
Change in MOCA score
Greater Montreal Cognitive Assessment (MOCA) score (ranging 0-30) is better
Time frame: 12 months
Change in cardiac function
Cardiac function will be measured by echocardiography. Left ventricular global longitudinal strain will be the primary measure of cardiac function.
Time frame: 12 months
Change in 6-minute walk distance
Functional capacity will be based on 6-minute walk test
Time frame: 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
Time frame: 12 and 24 months
Change in MOCA score
Greater Montreal Cognitive Assessment (MOCA) score (ranging 0-30) is better
Time frame: 24 months
Change in brain volume via MRI measurement
Time frame: 24 months
Change in hand grip strength
Time frame: 12 and 24 months
Change in heart failure classification
Based on New York Heart Association classification
Time frame: 12 and 24 months
Plan to share: No
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Baker Heart and Diabetes Institute