Heart Failure With Reduced Ejection FractionNCT04371731
A Single-centre Research Study to Evaluate the Care4Today® Heart Failure Platform.
A study testing Care4todayheart failure platform in people with Heart Failure With Reduced Ejection Fraction, run by Buckinghamshire Healthcare NHS Trust.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Care4todayheart failure platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- No sites listed yet
- Study dates
- 18 May 2015to 4 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
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.
Read the 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.
- Being tested
- Care4todayheart failure platform
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care4todayheart failure platformOther
Platform allowing patients to enter information about their health at home, namely weight and BP and medications
| Study group | Role | What they receive |
|---|---|---|
| Active Arm | Experimental | Active cohort will use the Care4today platform to help manage their heart failure Receives: Other: Care4todayheart failure platform |
| Control arm | No intervention | Control arm will contain standard of care heart failure treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital admissions
number of hospital admissions
Measured: 12 months
Secondary outcomes (7)
mean number of heart failure readmissions within 30 days of discharge
mean number of heart failure readmissions within 30 days of discharge
Measured: 30 days of discharge
all cause readmissions
mean number of all cause readmissions
Measured: 12 months
length of stay
- Mean, median (SD) days of length of stay (for admissions with a primary and secondary diagnosis of HF)
Measured: 12 months
weight change
Mean (SD) change in weight
Measured: 12 months
Blood pressure
- Proportion of patients achieving target for blood pressure (140/90mmHg or 130/80mmHg for patients with diabetes) at the end of the study
Measured: 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
Measured: 12 months
QOL
- Mean change in Quality of Life assessed by Minnesota Living with Heart Failure Questionnaire and EQ5D or EQVAS
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start18 May 2015
- Primary completion12 Dec 2017
- Study completion4 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two arms, one using the platform to help manage their heart failure and one standard of care.
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Buckinghamshire Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Cilag Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371731
- Sponsor's protocol ID
- RXQ682
- Status last verified
- Apr 2020
- First submitted
- 28 Apr 2020
- Last updated
- 1 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04371731
- Acronym / sponsor ID
- RXQ682
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Buckinghamshire Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- Janssen-Cilag Ltd.
- Study start
- 18 May 2015 (actual)
- Primary completion
- 12 Dec 2017 (actual)
- Study completion
- 4 Apr 2018 (actual)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two arms, one using the platform to help manage their heart failure and one standard of care.
| Arm | Type | Receives |
|---|---|---|
| Active Arm | Experimental | Other: Care4todayheart failure platformActive cohort will use the Care4today platform to help manage their heart failure |
| Control arm | No intervention | –Control arm will contain standard of care heart failure treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care4todayheart failure platformPlatform allowing patients to enter information about their health at home, namely weight and BP and medications | Other | Active Arm |
Primary outcome
Hospital admissions
Time frame: 12 months
number of hospital admissions
7 secondary outcomes
mean number of heart failure readmissions within 30 days of discharge
Time frame: 30 days of discharge
all cause readmissions
Time frame: 12 months
length of stay
Time frame: 12 months
weight change
Time frame: 12 months
Blood pressure
Time frame: 12 months
Hospital Anxiety and Depression Scale score
Time frame: 12 months
QOL
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Care4todayheart failure platform in people with Heart Failure With Reduced Ejection Fraction, run by Buckinghamshire Healthcare NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital admissions (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2020.