Rehabilitation Enablement in Chronic Heart Failure (REACH HF). A multicentre parallel group randomised controlled trial with parallel economic and process evaluation to assess the clinical effectiveness and cost-effectiveness of the REACH HF manual for patients and caregivers

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 324

Inclusion Criteria

1. Provision of informed consent to participate
2. Adults (aged =18 years)
3. Patients who have a confirmed diagnosis of systolic HF on echocardiography (i.e. left ventricular ejection fraction <45%) within the last 5 years
4. Patients who have experienced no deterioration of HF symptoms in the past 2 weeks resulting in hospitalisation or alteration of HF medication

Patients? caregivers who are aged 18 years or older may participate if they meet the following definition and provide informed consent to take part:
1. Someone who provides unpaid support to family or friends who could not manage without this help. This could be caring for a relative, partner or friend.
2. Unpaid support includes providing emotional support, prompting with taking medications, observing for signs and symptoms of heart failure, getting prescriptions, encouraging participation in social events, physical activity, helping with household tasks as well as providing physical care.

A patient may still participate in the study if s/he does not have an identified caregiver, or if the patient?s caregiver is not willing to participate. The caregiver component of the HF manual will not be applicable for such patients in the intervention group.

Exclusion Criteria

1. Patients who have undertaken cardiac rehabilitation (CR) within the last 12 months
2. Patients who have received an intracardiac defibrillator (ICD), cardiac resynchronisation therapy (CRT), or combined CRT/ICD device implanted in the last 6 months
3. Patients who have any of the following contraindications to exercise testing or exercise training (adapted from ESC HF guidelines) documented in their medical notes:
3.1. Early phase after acute coronary syndrome (up to 2 days)
3.2. Untreated lifethreatening cardiac arrhythmias
3.3. Acute heart failure (during the initial period of haemodynamic instability)
3.4. Uncontrolled hypertension (SBP >200 and/or DBP >100)
3.5. Advanced atrioventricular block
3.6. Acute myocarditis and pericarditis
3.7. Symptomatic aortic stenosis
3.8. Severe hypertrophic obstructive cardiomyopathy
3.9. Acute systemic illness
3.10. Intracardiac thrombus
3.11. Progressive worsening of exercise tolerance or dyspnoea at rest over previous 3?5 days
3.12. Significant ischaemia during low intensity exercise (<2 METs, <50 W)
3.13. Uncontrolled diabetes (blood glucose >16 mmol/l or HbA1C >9% or equivalent unit)
3.14. Recent embolism
3.15. Thrombophlebitis
3.16. New onset atrial fibrillation/atrial flutter
4. Patients who are in a long term care establishment or who are unwilling or unable to travel to research assessments or accommodate home visits
5. Patients who are unable to understand the study information or unable to complete the outcome questionnaires
6. Patients judged to be unable to participate in the study for any other reason (e.g. psychiatric disorder, diagnosis of dementia, life threatening comorbidity)
7. Patients participating in concurrent interventional research which may overburden the patient or confound data collection

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Minnesota living with Heart Failure® Questionnaire (MLHFQ); Timepoint(s): Baseline, +4, +6 and +12 months

Secondary Outcome Measures

Name	Time	Method

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