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CR: Developing an Intervention to Improve Acceptance of Referral in HF (CREATE-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04276675
Recruitment Status : Recruiting
First Posted : February 19, 2020
Last Update Posted : February 19, 2020
British Heart Foundation
Information provided by (Responsible Party):
University of Leicester

Brief Summary:

Background: There are proven benefits to people with chronic heart failure (CHF) participating in a cardiac rehabilitation (CR) programme, however uptake remains disappointingly low. Admission to hospital presents a significant opportunity to offer CR referral to such a patient population. It is believed that up to 75% of patients with CHF show signs of frailty at discharge which might impact on the rate of patients' acceptance of referral to CR.

Aim: To explore the impact of frailty on patient acceptance of referral to CR following admission to hospital with an episode of decompensated CHF.

Methods and expected outcome: We will conduct an observational study assessing the relationship between frailty and acceptance of referral to CR in this patient population. It will also explore what factors impact that relationship including demographic factors, measures of self-care and patient activation measure (PAM).

Condition or disease
Heart Failure Systolic Frailty

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Study Type : Observational
Estimated Enrollment : 203 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac Rehabilitation Programme in Patients Following Hospitalisation for Decompensated Chronic Heart Failure: the Development of an Intervention to Improve Patient Acceptance of Referral.
Actual Study Start Date : February 5, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Acceptance of referral to cardiac rehabilitation [ Time Frame: Pre-discharge ]
    Identify whether participant has been referred to CR

Secondary Outcome Measures :
  1. Acceptance of referral to cardiac rehabilitation [ Time Frame: 6 weeks post discharge ]
    Identify whether participant has been referred to CR

Other Outcome Measures:
  1. Identify patient, carer and health care professional perceived barriers and facilitators to referral to Cardiac Rehabilitation [ Time Frame: 18 months ]
    Qualitative data analysis of focus groups and staff survey data to identify themes indicating what the barriers and facilitators to acceptance of referral to CR are.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Observational cohort: All patients admitted to the participating hospital with an episode of decompensated chronic heart failure and referred to the Heart Failure Nursing Service (HFNS) who are eligible for referral to cardiac rehabilitation.

Focus groups: Participants of observational study; Carers of participants

Survey: Health care professionals involved in delivering or referring to cardiac rehabilitation to people with chronic heart failure.


Observational study:

Inclusion Criteria:

  • Clinical diagnosis of HFrEF confirmed by cardiac imaging within 3 years.
  • Current admission for which the primary reason was decompensated heart failure requiring IV diuretics
  • Referred to the acute trusts heart failure nursing service
  • Able to give informed consent
  • Able to communicate in spoken English

Exclusion Criteria:

  • Contraindications to participating in cardiac rehabilitation as detailed in ESC consensus statement e.g. uncontrolled hypertension severe aortic stenosis, unstable angina
  • Moderate to severe cognitive impairment
  • Patients with severe dependence prior to index admission (inability to carry out ADL)
  • Admitted from a nursing home
  • Resident 'out of area'
  • Significant co-morbidities that would limit participation in a cardiac rehabilitation programme e.g. neurodegenerative conditions
  • Previous recruitment onto this study

Focus groups:

Inclusion criteria:

Participants of the observational study and their carers


Inclusion criteria:

Health care professionals who refer to or deliver cardiac rehabilitation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04276675

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Contact: Hannah Waterhouse (0116) 258 3656

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United Kingdom
Glenfield Hospital Recruiting
Leicester, Leicestershire, United Kingdom, LE3 9QP
Contact: Hannah Waterhouse    (0116) 258 3656   
Sponsors and Collaborators
University of Leicester
British Heart Foundation
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Principal Investigator: Hannah Waterhouse University of Leicester
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Responsible Party: University of Leicester Identifier: NCT04276675    
Other Study ID Numbers: 0739
First Posted: February 19, 2020    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases
Pathologic Processes