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A Single-centre Research Study to Evaluate the Care4Today® Heart Failure Platform.

Primary Purpose

Heart Failure With Reduced Ejection Fraction

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Care4todayheart failure platform
Sponsored by
Buckinghamshire Healthcare NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure With Reduced Ejection Fraction

Eligibility Criteria

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

Inclusion Criteria:

  • Adults 18 years of age or older with the primary diagnosis of heart failure
  • Must have moderate to severe LVSD (ejection fraction <= 40%) confirmed by an echocardiogram and/or other cardiac imaging

Exclusion Criteria:

  • Patients with right heart failure as a consequence of respiratory disease
  • Patients with Heart Failure with preserved Ejection Fraction
  • Patients with significant learning disability, or severe mental health conditions
  • Patients with metabolic heart disease e.g. amyloid
  • Patients with severe non-operable valve disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Active Arm

    Control arm

    Arm Description

    Active cohort will use the Care4today platform to help manage their heart failure

    Control arm will contain standard of care heart failure treatment

    Outcomes

    Primary Outcome Measures

    Hospital admissions
    number of hospital admissions

    Secondary Outcome Measures

    mean number of heart failure readmissions within 30 days of discharge
    mean number of heart failure readmissions within 30 days of discharge
    all cause readmissions
    mean number of all cause readmissions
    length of stay
    o Mean, median (SD) days of length of stay (for admissions with a primary and secondary diagnosis of HF)
    weight change
    Mean (SD) change in weight
    Blood pressure
    o Proportion of patients achieving target for blood pressure (140/90mmHg or 130/80mmHg for patients with diabetes) at the end of the study
    Hospital Anxiety and Depression Scale score
    Mean change in Hospital Anxiety and Depression Scale (HADS) at the start and after 1 year the end of the study. Score on scale of 0-21, 0-7 = normal, 8-10 borderline, 11-21 abnormal. Higher score = worse outcome
    QOL
    o Mean change in Quality of Life assessed by Minnesota Living with Heart Failure Questionnaire and EQ5D or EQVAS

    Full Information

    First Posted
    April 28, 2020
    Last Updated
    April 30, 2020
    Sponsor
    Buckinghamshire Healthcare NHS Trust
    Collaborators
    Janssen-Cilag Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04371731
    Brief Title
    A Single-centre Research Study to Evaluate the Care4Today® Heart Failure Platform.
    Official Title
    A Single-centre Research Study to Evaluate the Impact of a Novel Care Pathway for Patients Diagnosed With Heart Failure (HF) Within Chiltern CCG, Supported by an Integrated Clinical Patient Record. Assessment of Patient Outcomes Following Implementation of Care4Today® Heart Failure Platform.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    May 18, 2015 (Actual)
    Primary Completion Date
    December 12, 2017 (Actual)
    Study Completion Date
    April 4, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Buckinghamshire Healthcare NHS Trust
    Collaborators
    Janssen-Cilag Ltd.

    4. Oversight

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

    5. Study Description

    Brief Summary
    A research study to evaluate the impact of a novel care pathway for patients diagnosed with Heart Failure within Chiltern CCG, supported by an integrated clinical patient record. Assessment of patient outcomes following implementation of Care4Today(R) Heart Failure Platform.
    Detailed Description
    This is an exploratory study to evaluate the impact of the novel Care4Today HF platform on a set of outcomes including hospital admission rate (primary diagnosis), 30 days post discharge readmission rate, length of hospital stay for patients with HF (primary and secondary diagnosis), patient quality of life, and patient clinical metrics. The study design includes comparison of two parallel cohorts: one where patients will be managed via the Care4Today HF platform (active cohort) and a second, where patients will be managed as per existing standards of care (control cohort). Evaluation phase: The evaluation phase will be set up to assess the potential benefits of the Care4Today HF platform. This will be implemented across 10 GP practices who will be part of the active cohort, within the Chiltern CCG region. The outcomes for these patients will be compared with the outcomes of patients in the control cohort over a one year period. Patients pathway (for the active cohort): Once the diagnosis of HF is confirmed, a HF specialist project nurse will register the patient on the Care4Today platform and provide the patient with instructions on how to use the patient portal, where patients can input various clinical measures, communicate with HCPs and track their condition. Complex patients, and/or patients that are deteriorating are referred to the community HF specialist nurse team where they will be monitored and managed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure With Reduced Ejection Fraction

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Two arms, one using the platform to help manage their heart failure and one standard of care.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    182 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Active Arm
    Arm Type
    Experimental
    Arm Description
    Active cohort will use the Care4today platform to help manage their heart failure
    Arm Title
    Control arm
    Arm Type
    No Intervention
    Arm Description
    Control arm will contain standard of care heart failure treatment
    Intervention Type
    Other
    Intervention Name(s)
    Care4todayheart failure platform
    Intervention Description
    Platform allowing patients to enter information about their health at home, namely weight and BP and medications
    Primary Outcome Measure Information:
    Title
    Hospital admissions
    Description
    number of hospital admissions
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    mean number of heart failure readmissions within 30 days of discharge
    Description
    mean number of heart failure readmissions within 30 days of discharge
    Time Frame
    30 days of discharge
    Title
    all cause readmissions
    Description
    mean number of all cause readmissions
    Time Frame
    12 months
    Title
    length of stay
    Description
    o Mean, median (SD) days of length of stay (for admissions with a primary and secondary diagnosis of HF)
    Time Frame
    12 months
    Title
    weight change
    Description
    Mean (SD) change in weight
    Time Frame
    12 months
    Title
    Blood pressure
    Description
    o Proportion of patients achieving target for blood pressure (140/90mmHg or 130/80mmHg for patients with diabetes) at the end of the study
    Time Frame
    12 months
    Title
    Hospital Anxiety and Depression Scale score
    Description
    Mean change in Hospital Anxiety and Depression Scale (HADS) at the start and after 1 year the end of the study. Score on scale of 0-21, 0-7 = normal, 8-10 borderline, 11-21 abnormal. Higher score = worse outcome
    Time Frame
    12 months
    Title
    QOL
    Description
    o Mean change in Quality of Life assessed by Minnesota Living with Heart Failure Questionnaire and EQ5D or EQVAS
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults 18 years of age or older with the primary diagnosis of heart failure Must have moderate to severe LVSD (ejection fraction <= 40%) confirmed by an echocardiogram and/or other cardiac imaging Exclusion Criteria: Patients with right heart failure as a consequence of respiratory disease Patients with Heart Failure with preserved Ejection Fraction Patients with significant learning disability, or severe mental health conditions Patients with metabolic heart disease e.g. amyloid Patients with severe non-operable valve disease

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Single-centre Research Study to Evaluate the Care4Today® Heart Failure Platform.

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