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

ISRCTN	ISRCTN86234930
DOI	https://doi.org/10.1186/ISRCTN86234930
Secondary identifying numbers	17779

Submission date: 13/11/2014
Registration date: 13/11/2014
Last edited: 10/02/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Rod Taylor
Scientific

PenTAG
Peninsula Medical School
Veysey Building
Salmon Pool Lane
Exeter
EX2 4SG
United Kingdom

Email	r.taylor@exeter.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	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
Study acronym	REACH HF - Main trial
Study objectives	The overarching aim of the REACH HF programme is to develop and evaluate a nurse facilitated, homebased heart failure (HF) Manual to enhance the quality of life and self-management of people with heart failure (and their caregivers). This trial will assess how effective the HF Manual is as a self-help manual for patients with systolic heart failure as well as usual care, compared to usual care alone. This study will also enable the research team to see whether the HF Manual is good value for money and to ensure the manual is delivered consistently.
Ethics approval(s)	14/NW/1351; First MREC approval date 06/11/2014
Health condition(s) or problem(s) studied	Topic: Primary Care; Subtopic: Cardiovascular disease, Primary care; Disease: All Diseases
Intervention	REACH HF Manual: A self-help home-based manual designed to be delivered by a specially trained facilitator; Follow Up Length: 12 month(s); Study Entry : Single Randomisation only
Intervention type	Other
Primary outcome measure	Minnesota living with Heart Failure® Questionnaire (MLHFQ); Timepoint(s): Baseline, +4, +6 and +12 months
Secondary outcome measures	N/A
Overall study start date	05/01/2015
Completion date	31/12/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 324; UK Sample Size: 324; Description: The trial aims to recruit 216 patients with systolic heart failure. The intervention is designed to benefit caregivers also, and so caregive
Key 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 patients caregiver is not willing to participate. The caregiver component of the HF manual will not be applicable for such patients in the intervention group.
Key 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 35 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
Date of first enrolment	05/01/2015
Date of final enrolment	31/12/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Peninsula Medical School

Exeter
EX2 4SG
United Kingdom

Sponsor information

Royal Cornwall Hospitals NHS Trust (UK)
Hospital/treatment centre

Treliske
Truro
TR1 3LJ
England
United Kingdom

"ROR"	https://ror.org/026xdcm93

Funders

Funder type

Government

National Institute for Health Research (UK)
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	23/12/2015		Yes	No
Results article	results	10/10/2018	29/01/2019	Yes	No
Results article	results	06/07/2020	08/07/2020	Yes	No
Other publications	Secondary analysis	09/02/2023	10/02/2023	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

10/02/2023: Publication reference added.
16/02/2021: Internal review.
08/07/2020: Publication reference added.
29/01/2019: Publication reference added
20/09/2016: Publication reference added.