Rehabilitation enablement in chronic heart failure
| ISRCTN | ISRCTN78539530 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78539530 |
| Secondary identifying numbers | 2012/004_3 |
- Submission date
- 07/07/2015
- Registration date
- 07/08/2015
- Last edited
- 18/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
This study forms one part of a wider research project led by a research team based in Cornwall, who are interested in improving the care provided to people with heart failure. The overall aim of the project is to develop and test a new self-help manual (the HF manual) for people with heart failure and for the caregivers that help them to manage the condition. The HF Manual has been designed for patients with a type of heart failure referred to as ‘heart failure with reduced ejection fraction’. In this type of heart failure, the heart muscle does not contract effectively and less blood is pumped out to the body. It is hoped that the HF Manual will also be appropriate for patients with another type of heart failure referred to as ‘heart failure with preserved ejection fraction (HFpEF)’. In this type of heart failure, the heart muscle contracts normally but does not relax as it should after contraction. The purpose of this study is to see if a larger study is feasible in patients with HFpEF. This study will assess the suitability of the HF Manual for HFpEF patients, and test the procedures for collecting research data in preparation for a larger study in the future.
Who can participate?
Patients aged 18 or over with HFpEF
What does the study involve?
Participants are randomly allocated to one of two groups: participants in the control group continue to receive their usual care, while patients in the intervention group receive the new HF Manual in addition to their usual care. It is not known whether the new manual is effective or not but this can be found out by comparing information collected from people in both groups. It is known that heart failure affects the lives not just of the people with the condition, but can also impact those family members and friends who help to support them. If patients have a family member or friend who provides unpaid support to help them manage the condition, they are also invited to take part in the study as a caregiver.
What are the possible benefits and risks of participating?
Participants will be helping to evaluate the effectiveness of the HF Manual. Although participants may not benefit personally, the information gathered from their participation in the study may help to improve the rehabilitation of patients with heart failure in the future. Participants are not expected to be harmed in any way by taking part in this study. When blood samples are taken, participants may feel some discomfort at the puncture site, although this is usually short lived. A total of about 8 ml (less than one tablespoon) of blood will be collected over the study period. Blood sampling can occasionally lead to localised bruising and discomfort and (rarely) infection at the site where the blood was taken. If participants are in the intervention group and receive the HF Manual, they may be asked questions about their experiences with heart failure and its impact on their day-to-day life which might be upsetting. This may be whilst working through some of the sections of the HF Manual with the facilitator and during the interviews with members of the research team if they choose to take part. The facilitators and researchers involved in the study are professionally trained and will ask questions sensitively. Participants do not have to answer any questions which cause them to feel upset. If participants do get upset, the facilitators and local researchers can refer patients to the heart failure nursing service or their GP. Attendance at research clinics may incur an expense to participants in the first instance. However, any travel expenses for taking part in this study, including those incurred through use of their own vehicle, will be reimbursed at public transport rates.
Where is the study run from?
NHS Tayside (UK)
When is the study starting and how long is it expected to run for?
June 2015 to October 2016
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Prof. Rod Taylor
Contact information
Scientific
University of Exeter
South Cloisters
St Luke's Campus
Exeter
EX1 2LU
United Kingdom
 ORCID ID |
0000-0002-6538-5760 |
|---|
Study information
| Study design | Parallel two-group randomised controlled pilot trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A single-centre randomised controlled pilot trial to assess the feasibility of a definitive trial of the clinical effectiveness and cost effectiveness of the HF Manual in patients with heart failure with preserved ejection fraction and their caregivers (REACH-HFpEF) |
| Study acronym | REACH HFpEF |
| Study hypothesis | To assess the feasibility of a definitive trial of the effectiveness of the HF Manual in patients with heart failure with preserved ejection fraction. |
| Ethics approval(s) | East of Scotland Research Ethics Service, 26/03/2015, ref: 15/ES/0036 |
| Condition | Heart failure |
| Intervention | 1:1 individual participant allocation to either: 1. REACH-HF Manual plus usual care (intervention group) or 2. Usual care alone (control group) |
| Intervention type | Other |
| Primary outcome measure | 1. Recruitment rate for participants (patients and caregivers) 2. Attrition and loss to follow up at 4 and 6 months 3. Completion and completeness of main trial outcome measures |
| Secondary outcome measures | 1. Fidelity of HF manual delivery by intervention facilitators 2. Acceptability of the intervention to HFpEF patients, their caregivers and facilitators 3. Acceptability of study participation to participants |
| Overall study start date | 01/06/2015 |
| Overall study end date | 31/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Participant inclusion criteria | 1. Male or female aged ≥18 years 2. Patients with heart failure, defined by the presence of at least one of the following symptoms at the time of screening: 2.1. Paroxysmal nocturnal dyspnoea 2.2. Orthopnoea 2.3. Dyspnoea on mild or moderate exertion AND at least one of the following signs prior to study entry: 2.4. Basal crepitations 2.5. Elevated jugular venous pressure 2.6. Lower extremity oedema 2.7. Chest radiograph demonstrating pleural effusion, pulmonary congestion or cardiomegaly 3. Patients with left ventricular ejection fraction (EF) ≥45% obtained within 6 months prior to randomization and after any myocardial infarction (MI) or other event that would affect EF (ideally obtained by echocardiography, although radionuclide ventriculography and angiography are acceptable) 4. Provision of informed consent to participate. |
| Participant exclusion criteria | 1. Patients who have undertaken cardiac rehabilitation (CR) within the last six months 2. Patients with severe chronic pulmonary disease defined as requiring home oxygen or hospitalization for exacerbation within 12 months, or significant chronic pulmonary disease in the opinion of the investigator 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 life-threatening 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. Recent-onset atrial fibrillation/atrial flutter (in the last 4 weeks) 4. Patients who are unable to understand the study information or unable to complete study procedures 5. Patients who are in a long-term care establishment or who are unwilling or unable to travel to research assessments or accommodate home visits 6. Patients judged to be unable to participate in the study for any other reason, e.g. psychiatric disorder, diagnosis of dementia, life-threatening co-morbidity 7. Patients participating in concurrent interventional research which may over-burden the patient or confound data collection |
| Recruitment start date | 30/06/2015 |
| Recruitment end date | 30/06/2016 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
United Kingdom
Sponsor information
Hospital/treatment centre
Royal Cornwall Hospital
Gloweth
Truro
TR1 3LJ
England
United Kingdom
"ROR" |
https://ror.org/026xdcm93 |
|---|
Funders
Funder type
Government
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 | 01/03/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | The authors are planning open access publication of the study results in Q4 2017/Q1 2018 in a peer reviewed journal. |
| IPD sharing plan | The authors confirm that all data underlying the findings will be made fully available without restriction. The authors will make the clinical and economic dataset available through the University of Exeter’s Institutional Repository – Open Research Exeter (see https://ore.exeter.ac.uk). Access to these data is permitted but controlled through requests made via the repository to the chief investigator (Professor Taylor: r.taylor@exeter.ac.uk). Although use is permitted, this will be on the basis that the source of the data is acknowledged (including the funder) and it includes reference to the data set ‘handle’. It is expected that this will be made available open access from Q2 2018. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 25/10/2016 | Yes | No | |
| Results article | results | 09/04/2018 | 29/01/2019 | Yes | No |
| Other publications | process evaluation | 06/01/2021 | 12/01/2021 | Yes | No |
| Other publications | Secondary analysis | 09/02/2023 | 10/02/2023 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 01/02/2021 | 18/09/2024 | Yes | No |
Editorial Notes
18/09/2024: Publication reference added.
10/02/2023: Publication reference added.
12/01/2021: Publication reference added.
29/01/2019: Publication reference added
03/10/2017: The overall trial end date was changed from 31/10/2016 to 31/12/2016. Publication and dissemination plan and IPD sharing statement added.
01/11/2016: Publication reference added.
