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

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.

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure With Reduced Ejection Fraction
• Intervention / Treatment: Other: Care4todayheart 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.

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Active Arm; Active cohort will use the Care4today platform to help manage their heart failure	Other: Care4todayheart failure platform; Platform allowing patients to enter information about their health at home, namely weight and BP and medications
NO_INTERVENTION: Control arm; Control arm will contain standard of care heart failure treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital admissions	number of hospital admissions	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean number of heart failure readmissions within 30 days of discharge	mean number of heart failure readmissions within 30 days of discharge	30 days of discharge
all cause readmissions	mean number of all cause readmissions	12 months
length of stay	o Mean, median (SD) days of length of stay (for admissions with a primary and secondary diagnosis of HF)	12 months
weight change	Mean (SD) change in weight	12 months
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	12 months
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	12 months
QOL	o Mean change in Quality of Life assessed by Minnesota Living with Heart Failure Questionnaire and EQ5D or EQVAS	12 months

Collaborators and Investigators

• Sponsor: Buckinghamshire Healthcare NHS Trust
• Collaborators: Janssen-Cilag Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 18, 2015
• Primary Completion (ACTUAL): December 12, 2017
• Study Completion (ACTUAL): April 4, 2018

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: April 30, 2020
• First Posted (ACTUAL): May 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 1, 2020
• Last Update Submitted That Met QC Criteria: April 30, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: RXQ682

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No