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

Primary Purpose

Heart Failure, Cognitive Impairment, Dementia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Disease management program
Sponsored by
Baker Heart and Diabetes Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Usual care

    Intervention

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Change in cardiac function
    Cardiac function will be measured by echocardiography. Left ventricular global longitudinal strain will be the primary measure of cardiac function.
    Change in 6-minute walk distance
    Functional capacity will be based on 6-minute walk test
    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
    Change in MOCA score
    Greater Montreal Cognitive Assessment (MOCA) score (ranging 0-30) is better
    Change in brain volume via MRI measurement
    Change in hand grip strength
    Change in heart failure classification
    Based on New York Heart Association classification

    Full Information

    First Posted
    September 27, 2023
    Last Updated
    October 11, 2023
    Sponsor
    Baker Heart and Diabetes Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06088212
    Brief Title
    Reducing Cognitive Impairment by Management of Heart Failure as a Modifiable Risk Factor
    Acronym
    Cog-HF
    Official Title
    Reducing Cognitive Impairment by Management of Heart Failure as a Modifiable Risk Factor: the Cog-HF Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    October 2025 (Anticipated)
    Study Completion Date
    July 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Baker Heart and Diabetes Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure, Cognitive Impairment, Dementia, Left Ventricular Dysfunction, Cognitive Change, Cognitive Decline

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    168 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Usual care
    Arm Type
    No Intervention
    Arm Description
    Usual care patients will continue with the hospital follow-up plan and routine preventive care after hospital discharge.
    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Intervention patients will receive a disease management program in addition to the usual care.
    Intervention Type
    Other
    Intervention Name(s)
    Disease management program
    Intervention Description
    The components of our DMP include: Intensive post-discharge education 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. 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. Exercise program delivered by an exercise physiologist 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.
    Primary Outcome Measure Information:
    Title
    Change in MOCA score
    Description
    Greater Montreal Cognitive Assessment (MOCA) score (ranging 0-30) is better
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Change in cardiac function
    Description
    Cardiac function will be measured by echocardiography. Left ventricular global longitudinal strain will be the primary measure of cardiac function.
    Time Frame
    12 months
    Title
    Change in 6-minute walk distance
    Description
    Functional capacity will be based on 6-minute walk test
    Time Frame
    12 and 24 months
    Title
    Change in quality of life
    Description
    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
    Title
    Change in MOCA score
    Description
    Greater Montreal Cognitive Assessment (MOCA) score (ranging 0-30) is better
    Time Frame
    24 months
    Title
    Change in brain volume via MRI measurement
    Time Frame
    24 months
    Title
    Change in hand grip strength
    Time Frame
    12 and 24 months
    Title
    Change in heart failure classification
    Description
    Based on New York Heart Association classification
    Time Frame
    12 and 24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Hospitalised with HF as primary or secondary diagnosis. At least mild cognitive impairment (CI) based on Montreal Cognitive Assessment (MoCA) on hospital discharge. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Quan Huynh
    Phone
    610385321833
    Email
    quan.huynh@baker.edu.au
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Thomas H Marwick, MBBS PhD MPH
    Organizational Affiliation
    Baker Heart and Diabetes Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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