Skip to main content
OpenTrials
Completed

NCT Number: NCT04371731

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Care4todayheart failure platform

Other

Platform allowing patients to enter information about their health at home, namely weight and BP and medications

Primary outcomes

  1. Hospital admissions

    Time frame: 12 months

    number of hospital admissions

Secondary outcomes

  1. mean number of heart failure readmissions within 30 days of discharge

    Time frame: 30 days of discharge

    mean number of heart failure readmissions within 30 days of discharge

  2. all cause readmissions

    Time frame: 12 months

    mean number of all cause readmissions

  3. length of stay

    Time frame: 12 months

    o Mean, median (SD) days of length of stay (for admissions with a primary and secondary diagnosis of HF)

  4. weight change

    Time frame: 12 months

    Mean (SD) change in weight

  5. Blood pressure

    Time frame: 12 months

    o Proportion of patients achieving target for blood pressure (140/90mmHg or 130/80mmHg for patients with diabetes) at the end of the study

  6. Hospital Anxiety and Depression Scale score

    Time frame: 12 months

    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

  7. QOL

    Time frame: 12 months

    o Mean change in Quality of Life assessed by Minnesota Living with Heart Failure Questionnaire and EQ5D or EQVAS

Sponsors and collaborators

Lead sponsor

Buckinghamshire Healthcare NHS Trust

Other

Collaborators

  • Janssen-Cilag Ltd.

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
May 1, 2020
Registry last updated
May 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.