CR: Developing an Intervention to Improve Acceptance of Referral in HF (CREATE-HF)
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| ClinicalTrials.gov Identifier: NCT04276675 |
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Recruitment Status :
Recruiting
First Posted : February 19, 2020
Last Update Posted : February 19, 2020
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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 |
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| Heart Failure Systolic Frailty |
Show detailed description
| 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 |
- Acceptance of referral to cardiac rehabilitation [ Time Frame: Pre-discharge ]Identify whether participant has been referred to CR
- Acceptance of referral to cardiac rehabilitation [ Time Frame: 6 weeks post discharge ]Identify whether participant has been referred to CR
- 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.
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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 |
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
Survey:
Inclusion criteria:
Health care professionals who refer to or deliver cardiac rehabilitation.
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 ClinicalTrials.gov identifier (NCT number): NCT04276675
| Contact: Hannah Waterhouse | (0116) 258 3656 | hw264@le.ac.uk |
| United Kingdom | |
| Glenfield Hospital | Recruiting |
| Leicester, Leicestershire, United Kingdom, LE3 9QP | |
| Contact: Hannah Waterhouse (0116) 258 3656 hw264@le.ac.uk | |
| Principal Investigator: | Hannah Waterhouse | University of Leicester |
| Responsible Party: | University of Leicester |
| ClinicalTrials.gov 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Heart Failure Heart Failure, Systolic Frailty |
Heart Diseases Cardiovascular Diseases Pathologic Processes |