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

Heart Failure With Reduced Ejection Fraction Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04371731
• Other study ID #: RXQ682
• Status: Completed
• Phase: N/A
• Start date: May 18, 2015
• Est. completion date: April 4, 2018

Study information

• Verified date: April 2020
• Source: Buckinghamshire Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: April 4, 2018
• Est. primary completion date: December 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Other:
• Care4todayheart failure platform
Platform allowing patients to enter information about their health at home, namely weight and BP and medications

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Buckinghamshire Healthcare NHS Trust	Janssen-Cilag Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital admissions	number of hospital admissions	12 months
Secondary	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
Secondary	all cause readmissions	mean number of all cause readmissions	12 months
Secondary	length of stay	o Mean, median (SD) days of length of stay (for admissions with a primary and secondary diagnosis of HF)	12 months
Secondary	weight change	Mean (SD) change in weight	12 months
Secondary	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
Secondary	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
Secondary	QOL	o Mean change in Quality of Life assessed by Minnesota Living with Heart Failure Questionnaire and EQ5D or EQVAS	12 months