Contact information
Type
Scientific
Primary contact
Prof Rod Taylor
ORCID ID
Contact details
PenTAG
Peninsula Medical School
Veysey Building
Salmon Pool Lane
Exeter
EX2 4SG
United Kingdom
-
r.taylor@exeter.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
17779
Study information
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
Acronym
REACH HF - Main trial
Study hypothesis
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
14/NW/1351; First MREC approval date 06/11/2014
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Phase III
Drug names
Primary outcome measure
Minnesota living with Heart Failure® Questionnaire (MLHFQ); Timepoint(s): Baseline, +4, +6 and +12 months
Secondary outcome measures
N/A
Overall trial start date
05/01/2015
Overall trial end date
31/12/2015
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
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
Participant 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
Recruitment start date
05/01/2015
Recruitment end date
31/12/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Peninsula Medical School
Exeter
EX2 4SG
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research (UK)
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26700291