Reducing Cognitive Impairment by Management of Heart Failure as a Modifiable Risk Factor (Cog-HF)

Baker Heart and Diabetes Institute

Status: Enrolling

Conditions: Cognitive Change; Cognitive Impairment; Cognitive Decline; Heart Failure; Left Ventricular Dysfunction; Dementia

Treatments: Other: Disease management program

Study type: Interventional

Funder types: Other

Identifiers

NCT06088212

P8510

Details and patient eligibility

About

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.

Enrollment: 168 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

168 participants in 2 patient groups

Usual care

No Intervention group

Description:

Usual care patients will continue with the hospital follow-up plan and routine preventive care after hospital discharge.

Intervention

Experimental group

Description:

Intervention patients will receive a disease management program in addition to the usual care.

Treatment:

Other: Disease management program