Clinical trial NCT04371731: 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
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure With Reduced Ejection Fraction
Lead sponsor: Buckinghamshire Healthcare NHS Trust
Sponsor class: OTHER
Collaborators: name: Janssen-Cilag Ltd.
First posted: 2020-05-01
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arms, one using the platform to help manage their heart failure and one standard of care.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Hospital admissions
timeFrame: 12 months
Secondary outcomes:
measure: mean number of heart failure readmissions within 30 days of discharge
timeFrame: 30 days of discharge
measure: all cause readmissions
timeFrame: 12 months
measure: length of stay
timeFrame: 12 months
measure: weight change
timeFrame: 12 months
measure: Blood pressure
timeFrame: 12 months
measure: Hospital Anxiety and Depression Scale score
timeFrame: 12 months
measure: QOL
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
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