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

NCT06088212 | Recruiting

• 1 other identifier: P8510
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in MOCA score

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

  12 months

Secondary Outcomes (7)

• Change in cardiac function

  12 months

• Change in 6-minute walk distance

  12 and 24 months

• Change in quality of life

  12 and 24 months

• Change in MOCA score

  24 months

• Change in brain volume via MRI measurement

  24 months

Study Arms (2)

Usual care

NO INTERVENTION

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

Intervention

EXPERIMENTAL

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

Other: Disease management program

Interventions

Disease management program OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalised with HF as primary or secondary diagnosis.
• At least mild cognitive impairment (CI) based on Montreal Cognitive Assessment (MoCA) on hospital discharge.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baker Heart and Diabetes Institute: lead

Study Sites (1)

Menzies Institute for Medical Research

Hobart, Tasmania, 7000, Australia

RECRUITING

MeSH Terms

Conditions

Heart Failure; Cognitive Dysfunction; Dementia; Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Ventricular Dysfunction

Study Officials

• Thomas H Marwick, MBBS PhD MPH

  Baker Heart and Diabetes Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Quan Huynh

CONTACT

610385321833; quan.huynh@baker.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 18, 2023
• Study Start: July 1, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 12, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)