NCT04371731

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2018

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 1, 2020

Completed
Last Updated

May 1, 2020

Status Verified

April 1, 2020

Enrollment Period

2.6 years

First QC Date

April 28, 2020

Last Update Submit

April 30, 2020

Conditions

Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (1)

  • Hospital admissions

    number of hospital admissions

    12 months

Secondary Outcomes (7)

  • mean number of heart failure readmissions within 30 days of discharge

    30 days of discharge

  • all cause readmissions

    12 months

  • length of stay

    12 months

  • weight change

    12 months

  • Blood pressure

    12 months

  • +2 more secondary outcomes

Study Arms (2)

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

Care4todayheart failure platformOTHER

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

Active Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two arms, one using the platform to help manage their heart failure and one standard of care.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2020

First Posted

May 1, 2020

Study Start

May 18, 2015

Primary Completion

December 12, 2017

Study Completion

April 4, 2018

Last Updated

May 1, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share