Condition category
Circulatory System
Date applied
13/11/2014
Date assigned
13/11/2014
Last edited
20/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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 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.

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 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

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

Sponsor information

Organisation

Royal Cornwall Hospitals NHS Trust (UK)

Sponsor details

Treliske
Truro
TR1 3LJ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26700291

Publication citations

Additional files

Editorial Notes

20/09/2016: Publication reference added.