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

NCT ID: NCT04371731

Last Updated: 2020-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-18
• Study Completion Date: 2018-04-04

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.

Conditions

Heart Failure With Reduced Ejection Fraction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Active Arm

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

Group Type: EXPERIMENTAL

Care4todayheart failure platform

Intervention Type: OTHER

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

Control arm

Control arm will contain standard of care heart failure treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Care4todayheart failure platform

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag Ltd.

INDUSTRY

Sponsor Role: collaborator

Buckinghamshire Healthcare NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

RXQ682

Identifier Type: -

Identifier Source: org_study_id