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

Heart Failure Clinical Trial

— CREATE-HF  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04276675
• Other study ID #: 0739
• Status: Completed
• Start date: February 5, 2020
• Est. completion date: November 1, 2022

Study information

• Verified date: May 2022
• Source: University of Leicester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

Trial Design: Mixed method approach to development of an intervention: observational cohort study, semi-structured interviews, focus groups, staff survey, theory informed intervention development using 'The Behaviour Change Wheel'.

Trial Participants:

1. Patients admitted to hospital for an episode of decompensated heart failure who have been referred to the Heart Failure Nursing Service (HFNS) and are eligible for referral for cardiac rehabilitation.

2. Patients who have been referred to cardiac rehabilitation from the HFNS, Cardiology outpatients and general practice.

3. Health care professionals involved in the referral to or provision of cardiac rehabilitation services for people with chronic heart failure

Planned Sample Size:

203 patients in observational study; 8 to 40 participants in semi-structured interviews;10 to 15 health care professionals in focus groups; 40 health care professionals questionnaire

Follow-up duration:

Part 1 of the study: Observational Cohort: from discharge to 6 weeks post discharge; Part 2 of the study: Semi-structured interviews: participants have single semi-structured interview and given the opportunity to feedback on final proposed intervention Focus groups: cardiac rehabilitation team health care professionals participate in one focus group and feedback on final proposed intervention. Part 3 of study: Health care professional: single participation in survey and subgroup of HCP feedback on final proposed intervention

Planned Trial Period 24 months (including feasibility study of intervention)

Primary Objective: The primary objective of this study is to determine the key modifiable patient related factors associated with the acceptance of referral to cardiac rehabilitation in patients post discharge following an episode of decompensated chronic heart failure.

Secondary Objectives: Using the Behaviour Change wheel synthesize the data from the observational study, stakeholder perspectives and the literature on behaviour change interventions, develop a theory based intervention to increase the uptake of referral to cardiac rehabilitation in patients post discharge following an episode of decompensated chronic heart failure.

Primary Endpoint:

Observational study: Uptake of referral to cardiac rehabilitation by patients following an episode of decompensated heart failure at baseline visit.

Semi-structured interviews, focus groups and staff survey: Identify patient, and health care professional perceived barriers and facilitators to the uptake of referral to cardiac rehabilitation by patients following an episode of decompensated heart failure.

Secondary Endpoints:

Observational study: Uptake of referral to cardiac rehabilitation by patients following an episode of decompensated heart failure at 6 weeks post discharge.

Semi-structured interviews, focus groups and staff survey: Identify the impact of COVID 19 pandemic on the uptake of referral and participation in cardiac rehabilitation by patients following an episode of decompensated heart failure.

In consultation with experts in theory based interventions, data from all steps of the programme of study will be used to develop an intervention aimed at improving rate of acceptance of referral to CR in this patient population.

Further stakeholder involvement The intervention will be presented back in written form to interviewees and focus group members for further comment either written or via telephone contact. Health care professionals (HFNS team and CR team) will be invited for feedback on expected effectiveness and acceptability following which further adaptation of the intervention may occur

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Observational study:

Inclusion Criteria:

• 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

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

Semi-structured interviews: Purposive sampling

Inclusion criteria:

• 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

Exclusion criteria:

• Contraindications to participating in cardiac rehabilitation as detailed in ESC consensus statement (See Appendix D) e.g. uncontrolled hypertension, severe aortic stenosis, unstable angina

• Moderate to severe cognitive impairment

• Nursing home resident

• Significant co-morbidities that would limit participation in a cardiac rehabilitation programme e.g. neurodegenerative conditions

• Previous recruitment onto this study

Focus groups: convenience sampling

Inclusion criteria:

Staff from study site who are involved in the provision of cardiac rehabilitation to people with heart failure will be eligible to participate in the focus group.

Survey: convenience sampling

Inclusion criteria:

Health care professionals who refer to or deliver cardiac rehabilitation.

Related Conditions & MeSH terms

• Frailty
• Heart Failure

Locations

Country	Name	City	State
United Kingdom	Glenfield Hospital	Leicester	Leicestershire

Sponsors (2)

Lead Sponsor	Collaborator
University of Leicester	British Heart Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptance of referral to cardiac rehabilitation	Identify whether participant has been referred to CR	Within 7 days from baseline visit
Primary	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	Acceptance of referral to cardiac rehabilitation	Identify whether participant has been referred to CR	6 weeks post discharge
Secondary	Qualitative evaluation of impact of COVID 19 on acceptance of referral to cardiac rehabilitation service	This study was recruiting during the COVID 19 pandemic. Interviews and focus groups will be used to identify the impact of COVID 19 on the uptake of referral to cardiac rehabilitation by people with heart failure. Outcome measures from these cannot be counted and data will be analysed using qualitative methods to identify themes representing meanings associated with participants' disclosures.	6 weeks