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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBaker Heart and Diabetes Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Hospitalised with HF as primary or secondary diagnosis.

At least mild cognitive impairment (CI) based on Montreal Cognitive Assessment (MoCA) on hospital discharge.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Disease management program

    Other intervention

    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.

Treatment groups

168 Participants
are divided into 2 treatment groups
Group A: Usual careNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in MOCA score

Greater Montreal Cognitive Assessment (MOCA) score (ranging 0-30) is better

Time frame
12 months

Secondary outcomes

1

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
2

Change in 6-minute walk distance

Functional capacity will be based on 6-minute walk test

Time frame
12 and 24 months
3

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
4

Change in MOCA score

Greater Montreal Cognitive Assessment (MOCA) score (ranging 0-30) is better

Time frame
24 months

Other outcomes

Sponsors and contacts

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