A Single-centre Research Study to Evaluate the Care4Today... | NCT04371731

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

NCT04371731

Sponsor

Buckinghamshire Healthcare NHS Trust

Status

Completed

Last Update Posted

May 1, 2020Actual

Enrollment

182Actual

Phase

Not Applicable

Conditions

Heart Failure With Reduced Ejection Fraction

Interventions

Care4todayheart failure platform

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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.

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 18, 2015Actual

Primary Completion Date

Dec 12, 2017Actual

Completion Date

Apr 4, 2018Actual

First Submitted Date

Apr 28, 2020

First Submission Date that Met QC Criteria

Apr 30, 2020

First Posted Date

May 1, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2020

Last Update Posted Date

May 1, 2020Actual

Name	Class
Janssen-Cilag Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

182Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active Arm	Experimental	Active cohort will use the Care4today platform to help manage their heart failure	Other: Care4todayheart failure platform
Control arm	No Intervention	Control arm will contain standard of care heart failure treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Care4todayheart failure platform	Other	Platform allowing patients to enter information about their health at home, namely weight and BP and medications	Active Arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided