Development and Feasibility Testing of a Behavioural Intervention Targeting Multiple Lifestyle Behaviours to Improve Long Term Outcomes Following Liver Transplantation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility testing of the intervention
研究概览
简要总结
(i) To develop a behavioural intervention that supports healthcare professionals to effectively deliver lifestyle behaviour change of patients undergoing liver transplantation
(ii) To assess the acceptability and feasibility of the behavioural intervention during routine practice
详细描述
BACKGROUND
Liver transplantation is the most effective treatment for decompensated chronic liver disease and is associated with improvements in life expectancy and quality of life(1). Recent advances in immunosuppressive therapy; greater surgical and anaesthetic expertise and optimised risk assessment procedures have shown to be associated with improvements in 90 day, 1 and 5 year survival (2). However, non-liver causes of death are on the increase with malignancy (22%), cardiovascular disease (11%), infection (9%) and renal failure (6%) becoming leading causes of death at one year (3)
It is well recognised that liver transplantation is associated with the onset of a number of conditions that increase risk of early mortality, including new onset diabetes, hypertension and dyslipidaemia (4,5). These conditions have the potential to be prevented or improved by behavioural intervention targeting health and lifestyle behaviours including physical activity, diet, smoking and medication adherence (6). Lifestyle factors are central to both survival on the waiting list and long-term post transplant survival. Therefore it is important to support patients to make positive and sustainable lifestyle behaviour changes. However, this represents a complex medical challenge because rarely are clinical teams trained to target lifestyle behaviour change in a meaningful/personalised way.
AIMS OF THE STUDY
The aim is to develop a behavioural intervention that can be used by all medical personnel involved in the care of patients being assessed for transplantation, whilst listed for transplantation and post transplantation to improve long-term outcomes. The intervention will be co-developed by clinicians and patients to ensure it is fit for purpose. Healthcare professionals will be trained to target a range of health and lifestyle behaviours using evidence-based behavioural strategies. It is hoped this will lead to improvements in long-term survival by reducing modifiable risk factors for mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 years
- •Undergoing or planned to undergo liver transplant assessment, listed for liver transplantation or have undergone liver transplantation at the Freeman Hospital
- •Willing to participate in the study and able to provide written informed consent
排除标准
- •Patients who can't speak English and require the use of an interpreter.
- •Those who do not attend the Freeman Hospital for follow up care
结局指标
主要结局
Feasibility testing of the intervention
时间窗: 1 year
Qualitative assessment of the behavioural intervention by focus groups and interviews with patients and healthcare professionals
次要结局
- renal dysfunction(1 year)
- Exercise capacity(1 year)
- Hypertension(1 year)
- Weight(1 year)
- Diabetes(1 year)