A Single-centre Research Study to Evaluate the Care4Today® Heart Failure Platform.
Primary Purpose
Heart Failure With Reduced Ejection Fraction
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Care4todayheart failure platform
Sponsored by
About this trial
This is an interventional prevention trial for Heart Failure With Reduced Ejection Fraction
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Active Arm
Control arm
Arm Description
Active cohort will use the Care4today platform to help manage their heart failure
Control arm will contain standard of care heart failure treatment
Outcomes
Primary Outcome Measures
Hospital admissions
number of hospital admissions
Secondary Outcome Measures
mean number of heart failure readmissions within 30 days of discharge
mean number of heart failure readmissions within 30 days of discharge
all cause readmissions
mean number of all cause readmissions
length of stay
o Mean, median (SD) days of length of stay (for admissions with a primary and secondary diagnosis of HF)
weight change
Mean (SD) change in weight
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
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
QOL
o Mean change in Quality of Life assessed by Minnesota Living with Heart Failure Questionnaire and EQ5D or EQVAS
Full Information
NCT ID
NCT04371731
First Posted
April 28, 2020
Last Updated
April 30, 2020
Sponsor
Buckinghamshire Healthcare NHS Trust
Collaborators
Janssen-Cilag Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04371731
Brief Title
A Single-centre Research Study to Evaluate the Care4Today® Heart Failure Platform.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 18, 2015 (Actual)
Primary Completion Date
December 12, 2017 (Actual)
Study Completion Date
April 4, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Buckinghamshire Healthcare NHS Trust
Collaborators
Janssen-Cilag Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Reduced Ejection Fraction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two arms, one using the platform to help manage their heart failure and one standard of care.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
182 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Arm
Arm Type
Experimental
Arm Description
Active cohort will use the Care4today platform to help manage their heart failure
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Control arm will contain standard of care heart failure treatment
Intervention Type
Other
Intervention Name(s)
Care4todayheart failure platform
Intervention Description
Platform allowing patients to enter information about their health at home, namely weight and BP and medications
Primary Outcome Measure Information:
Title
Hospital admissions
Description
number of hospital admissions
Time Frame
12 months
Secondary Outcome Measure Information:
Title
mean number of heart failure readmissions within 30 days of discharge
Description
mean number of heart failure readmissions within 30 days of discharge
Time Frame
30 days of discharge
Title
all cause readmissions
Description
mean number of all cause readmissions
Time Frame
12 months
Title
length of stay
Description
o Mean, median (SD) days of length of stay (for admissions with a primary and secondary diagnosis of HF)
Time Frame
12 months
Title
weight change
Description
Mean (SD) change in weight
Time Frame
12 months
Title
Blood pressure
Description
o Proportion of patients achieving target for blood pressure (140/90mmHg or 130/80mmHg for patients with diabetes) at the end of the study
Time Frame
12 months
Title
Hospital Anxiety and Depression Scale score
Description
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
Time Frame
12 months
Title
QOL
Description
o Mean change in Quality of Life assessed by Minnesota Living with Heart Failure Questionnaire and EQ5D or EQVAS
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Single-centre Research Study to Evaluate the Care4Today® Heart Failure Platform.
We'll reach out to this number within 24 hrs