CR: Developing an Intervention to Improve Acceptance of Referral in HF

NCT04276675 | Completed

• 1 other identifier: 0739
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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).

Conditions

Heart Failure; Frailty

Outcome Measures

Primary Outcomes (2)

• Acceptance of referral to cardiac rehabilitation

  Identify whether participant has been referred to CR

  Within 7 days from baseline visit

• Qualitative evaluation of impact of offer of referral to cardiac rehabilitation service

  Health care professionals offer referral to cardiac rehabilitation to people with heart failure as part of their ongoing treatment. Interviews and focus groups will be used to identify patient and health care professional perceived barriers and facilitators to the uptake of referral to cardiac rehabilitation by patients. Outcome measures from these cannot be counted and the data will be analysed using qualitative methods to identify themes representing the meanings associated with the participants' disclosures.

  6 weeks

Secondary Outcomes (2)

• Acceptance of referral to cardiac rehabilitation

  6 weeks post discharge

• Qualitative evaluation of impact of COVID 19 on acceptance of referral to cardiac rehabilitation service

  6 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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. Semi-structured interviews: Participants of observational study; people with heart failure eligible for CR and referred to either the acute trust's heart failure nursing service and/ or cardiac rehabilitation team. Survey: Health care professionals involved in delivering or referring to cardiac rehabilitation to people with chronic heart failure.

You may qualify if:

• Clinical diagnosis of chronic heart failure confirmed by cardiac imaging.
• 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

You may not qualify if:

• 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
• Semi-structured interviews: Purposive sampling
• Patients with chronic heart failure who fulfil the criteria for referral to the cardiac rehabilitation service will be eligible to participate in the interviews if they are:
• Age 18 years or over
• Have a clinical diagnosis of CHF confirmed by cardiac imaging.
• Referred to the acute trusts heart failure nursing service and/or cardiac rehabilitation team
• Able to give informed consent
• Able to communicate in spoken English
• Contraindications to participating in cardiac rehabilitation as detailed in ESC consensus statement (See Appendix D) e.g. uncontrolled hypertension, severe aortic stenosis, unstable angina

Sponsors & Collaborators

• University of Leicester: lead
• British Heart Foundation: collaborator

Study Sites (1)

Glenfield Hospital

Leicester, Leicestershire, LE3 9QP, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure; Frailty

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hannah Waterhouse

  University of Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 19, 2020
• Study Start: February 5, 2020
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: September 15, 2023

Record last verified: 2022-05

Locations

GB (1)