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

  • STATUS
    Recruiting
  • participants needed
    203
  • sponsor
    University of Leicester
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Updated on 16 February 2024
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heart failure
diuretics
chronic heart failure

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, 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 HFrEF who have been referred to the Heart Failure Nursing Service (HFNS) and are eligible for referral for cardiac rehabilitation.
  2. Carers of patient participants
  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; 50 participants in focus groups; 40 health care professionals

Follow-up duration:

Part 1 of the study: Observational Cohort: from discharge to 6 weeks post discharge; Part 2 of the study: Focus groups: participation in 1 focus group not before their 6 week follow up from observational study. Feedback on final proposed intervention. Carers: participate in one focus group not before patient's 6 week follow up visit. ; 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.

Secondary Endpoints:

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

Focus groups and staff survey: Identify patient, carer 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.

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 focus groups 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

Details
Condition systolic heart failure, Frailty
Age 18years - 100years
Clinical Study IdentifierNCT04276675
SponsorUniversity of Leicester
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Participants of the observational study and their carers
Survey
Inclusion criteria
Health care professionals who refer to or deliver cardiac rehabilitation

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
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