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Source: isrctn - Le promoteur: Royal Cornwall Hospitals NHS Trust
Royal Cornwall Hospitals NHS Trust MAJ Il y a 4 ans

Rehabilitation enablement in chronic heart failure 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. We will assess the suitability of the HF Manual for HFpEF patients, and test our 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? Patients will be allocated to one of two groups: patients in the control group will continue to receive their usual care, while patients in the intervention group will receive the new HF Manual in addition to their usual care. We don’t know if the new manual is effective or not but we can find out by comparing information collected from people in both groups. We know 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

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