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

Royal Cornwall Hospitals NHS Trust (UK)0 sites324 target enrollmentNovember 13, 2014

Overview

2015 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/26700291 protocol 2018 Results article in https://pubmed.ncbi.nlm.nih.gov/30304644/ results (added 29/01/2019) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32631324/ results (added 08/07/2020) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/36759035/ Secondary analysis (added 10/02/2023)

Registry

who.int

Start Date

November 13, 2014

End Date

December 31, 2015

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

Royal Cornwall Hospitals NHS Trust (UK)

•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.

•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