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| Name | Class |
|---|---|
| British Heart Foundation | OTHER |
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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).
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:
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
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptance of referral to cardiac rehabilitation | Identify whether participant has been referred to CR | 6 weeks post discharge |
| Qualitative evaluation of impact of COVID 19 on acceptance of referral to cardiac rehabilitation service |
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Observational study:
Inclusion Criteria:
Exclusion Criteria:
Semi-structured interviews: Purposive sampling
Inclusion criteria:
Exclusion criteria:
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.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Hannah Waterhouse | University of Leicester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glenfield Hospital | Leicester | Leicestershire | LE3 9QP | United Kingdom |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |