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

Not Applicable

Recruiting

• Conditions: Cognitive Impairment; Left Ventricular Dysfunction; Heart Failure; Dementia; Cognitive Change; Cognitive Decline
• Interventions: Other: Disease management program

• Registration Number: NCT06088212
• Lead Sponsor: Baker Heart and Diabetes Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-27
• Study First Submitted QC: 2023-10-11
• Study First Posted: 2023-10-18
• Status Verified: 2023-11
• Study Start: 2024-07-01
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12
• Primary Completion: 2025-10
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 168

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in MOCA score	12 months	Greater Montreal Cognitive Assessment (MOCA) score (ranging 0-30) is better

Secondary Outcome Measures

Name	Time	Method
Change in 6-minute walk distance	12 and 24 months	Functional capacity will be based on 6-minute walk test
Change in hand grip strength	12 and 24 months
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 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 heart failure classification	12 and 24 months	Based on New York Heart Association classification
Change in brain volume via MRI measurement	24 months

Trial Locations

Locations (1)

Menzies Institute for Medical Research; 🇦🇺 Hobart, Tasmania, Australia