Trial of a facilitated home-based rehabilitation intervention in patients with heart failure

INTERVENTION: Randomisation will be done via the study web portal and participants will be randomly allocated in a 1:1 ratio to either intervention (REACH‐HF plus usual care) or control (usual care only) groups. Usual care will be determined by local NHS policies. ?Randomisation will be stratified by investigator site and minimised on sex, baseline pro‐brain‐natriuretic peptide (NT‐proBNP) levels (=2000 vs. >2000 pg/mL), and ejection fraction (45‐55% vs. >55%). The research team will be blinded to the treatment allocation. Only the rehab team will receive the allocation details. REACH‐HF is a home‐based cardiac rehabilitation programme providing comprehensive self‐care support to the patient and their caregiver (http://sites.exeter.ac.uk/reach‐hf/). This comprehensive intervention includes four core elements: 1. REACH‐HF Manual for patients with a choice of two structured exercise programs: a chair‐based exercise and a progressive walking training program. Patients are advised to exercise =3 times per week, starting from their own personal level and gradually building up over 2‐3 months in time/distance/walking pace. 2. Patient ‘Progress Tracker’ – an interactive booklet designed to facilitate learning from experience to record symptoms, physical activity, and other actions related to self‐care. Patient’s record: (1) how long/far they plan to walk, (2) whether they have done it, (3) how it felt to identify whether they should be moving up or down in efforts next time and (4) their weekly steps per minute (pace). 3. ‘Family and Friends Resource’ – a manual for use by caregivers aimed to increase their understanding of HF and caregiver physical and mental wellbeing. 4. Facilitation by hea CONDITION: Exercise‐based cardiac rehabilitation in patients with heart failure with preserved ejection fraction (HFpEF). ; Circulatory System ; Heart failure PRIMARY OUTCOME: Change in Minnesota Living with Heart Failure Questionnaire (MLWHF) score from baseline to 12 months. SECONDARY OUTCOME: ; Patients:; 1. Exercise capacity measured using the Incremental Shuttle Walk Test (ISWT), performed if COVID‐19 restrictions permit participants to attend clinic visits, measured at baseline, 4, and 12 months; 2. Psychological wellbeing measured using Hospital Depression and Anxiety Scale (HADS) at baseline, 4, and 12 months; 3. Level of physical activity measured using accelerometry (GENEActive device) at baseline, 4, and 12 months; 4. Generic health‐related quality of life measured using the EQ‐5D‐5L and Short‐Form‐12 at baseline, 4, and 12 months; 5. Self‐management measured using the Self‐care of Heart Failure Index (SCHFI) & Self‐efficacy for key‐behaviours questionnaire at baseline, 4, and 12 months; 6. Frailty measured using the Clinical Frailty Scale at baseline, 4, and 12 months; 7. Prognostic biomarker measured from NT‐proBNP at baseline, 4, and 12 months; 8. Clinical Events measured by all‐cause and heart failure‐specific deaths and hospital admissions at baseline, 4, and 12 months; 9. Adverse Events and Serious Adverse events recorded at baseline, 4, and 12 months; ; Caregivers:; 1. Health‐related quality of life measured using EQ‐5D‐5L and Family Caregiver Quality of Life Scale questionnaire (FAMQoL) at baseline, 4, and 12 months; 2. Psychological Wellbeing measured using Hospital Depression and Anxiety Scale (HADS) at baseline, 4, and 12 months; 3. Self‐management measured using Caregiver Contribution to Self‐care of HF Index questionnaire (CC‐SCHFI)at baseline, 4, and 12 months; 4. Burden measured using Caregiver Burden for HF Questionnaire (CBQ‐HF) at baseline, 4, and 12 months; INCLUSION CRITERIA: Patient: 1. Women or men aged =18 years 2. Currently symptomatic HF (NYHA Class II‐IV) 3. Prescribed loop diuretics and the need for intermittent loop diuretics for the management of symptoms or signs of congestion 4. Left ventricular ejection fraction (by echocardiography) =45% within 12 months prior to randomisation 5. At least one of the following risk factors: 5.1. Hospital admission in last 12 months for which HF was a major contributor 5.2. N‐terminal proBNP >300 pg/ml for patients with sinus rhythm 5.3. N‐terminal proBNP >900 pg/ml for patients in atrial fibrillation 6. Informed consent to participate Caregivers: 1. Women or men aged =18 years 2. Providing unpaid support to patients