Lifestyle Intervention For Liver Transplantation

Not Applicable

• Conditions: Liver Disease

• Registration Number: NCT02696655
• Lead Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust

Brief Summary

(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

Detailed Description

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.

OBJECTIVES

This study will develop and assess acceptability and feasibility of a multifaceted behaviour change intervention. The intervention will be designed to train healthcare professionals to use behavioural strategies to target key lifestyle behaviours in the context of liver transplantation, and to equip patients with behavioural skills to make positive changes to a range of lifestyle behaviours. In reality, this could be the most cost effective model to be able to enable lifestyle change for transplant patients. These healthcare professionals are front line staff and work with high volumes of transplant patients.

PRIMARY RESEARCH QUESTION Is a multifaceted behavioural intervention co-developed by healthcare professionals and patients acceptable and feasible and can it be delivered faithfully during routine clinical practice?

Objectives The objectives of this study are:- i) To co-develop an evidence-based, multifaceted behavioural intervention for delivery during routine clinical consultations ii) To develop a training programme that equips clinicians with the knowledge, skills and confidence to deliver a behavioural intervention during routine clinical practice iii) To determine whether the behavioural intervention is acceptable and feasible to both healthcare professionals and patients iv) To assess whether the behavioural intervention can be delivered faithfully during routine clinical practice v) To optimise the behavioural intervention based on feedback from clinicians and patients.

vi) To assess whether the intervention impacts positively on clinical outcomes (e.g., blood pressure, HbA1c levels) vii) To inform the design of a large randomised controlled trial if appropriate

Study Timeline

• Study First Submitted: 2015-10-12
• Status Verified: 2016-02
• Study Start: 2016-02
• Study First Submitted QC: 2016-03-01
• Last Update Submitted: 2016-03-01
• Study First Posted: 2016-03-02
• Last Update Posted: 2016-03-02
• Primary Completion: 2017-11
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility testing of the intervention	1 year	Qualitative assessment of the behavioural intervention by focus groups and interviews with patients and healthcare professionals

Secondary Outcome Measures

Name	Time	Method
renal dysfunction	1 year	change in estimated glomerular filtration rate
Exercise capacity	1 year	Assessed by pedometers (average steps per day taken assessed over one week)
Hypertension	1 year	Change in blood pressure from baseline
Weight	1 year	change in weight since baseline
Diabetes	1 year	change in HBA1c from baseline

Trial Locations

Locations (1)

Dept of perioperative and critical care medicine, Freeman Hospital; 🇬🇧 Newcastle upon tyne, Tyne and Wear, United Kingdom