Lifestyle Intervention For Liver Transplantation

Liver Disease Clinical Trial

— LIFT  

Official title:

Development and Feasibility Testing of a Behavioural Intervention Targeting Multiple Lifestyle Behaviours to Improve Long Term Outcomes Following Liver Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02696655
• Other study ID #: 7526
• Status: Not yet recruiting
• Phase: N/A
• First received: October 12, 2015
• Last updated: March 1, 2016
• Start date: February 2016
• Est. completion date: February 2018

Study information

• Verified date: February 2016
• Source: Newcastle-upon-Tyne Hospitals NHS Trust
• Contact: James Prentis, MBBS
• Phone: 01912336161
• Email: james.prentis[@]nuth.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: February 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Liver Disease
• Liver Diseases

Intervention

Behavioral:
• Behavioural intervention
Behavioural intervention administered by healthcare professionals targetting multiple lifestyle behaviours

Locations

Country	Name	City	State
United Kingdom	Dept of perioperative and critical care medicine, Freeman Hospital	Newcastle upon tyne	Tyne and Wear

Sponsors (1)

Lead Sponsor	Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (6)

Benhamou PY, Penfornis A. Natural history, prognosis, and management of transplantation-induced diabetes mellitus. Diabetes Metab. 2002 Jun;28(3):166-75. Review. — View Citation

Germani G, Theocharidou E, Adam R, Karam V, Wendon J, O'Grady J, Burra P, Senzolo M, Mirza D, Castaing D, Klempnauer J, Pollard S, Paul A, Belghiti J, Tsochatzis E, Burroughs AK. Liver transplantation for acute liver failure in Europe: outcomes over 20 ye — View Citation

Gisbert C, Prieto M, Berenguer M, Bretó M, Carrasco D, de Juan M, Mir J, Berenguer J. Hyperlipidemia in liver transplant recipients: prevalence and risk factors. Liver Transpl Surg. 1997 Jul;3(4):416-22. — View Citation

Luca L, Westbrook R, Tsochatzis EA. Metabolic and cardiovascular complications in the liver transplant recipient. Ann Gastroenterol. 2015 Apr-Jun;28(2):183-192. Review. — View Citation

Pfitzmann R, Nüssler NC, Hippler-Benscheidt M, Neuhaus R, Neuhaus P. Long-term results after liver transplantation. Transpl Int. 2008 Mar;21(3):234-46. Epub 2007 Nov 21. — View Citation

Tsochatzis EA, Bosch J, Burroughs AK. Liver cirrhosis. Lancet. 2014 May 17;383(9930):1749-61. doi: 10.1016/S0140-6736(14)60121-5. Epub 2014 Jan 28. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility testing of the intervention	Qualitative assessment of the behavioural intervention by focus groups and interviews with patients and healthcare professionals	1 year	No
Secondary	Exercise capacity	Assessed by pedometers (average steps per day taken assessed over one week)	1 year	No
Secondary	Hypertension	Change in blood pressure from baseline	1 year	No
Secondary	Weight	change in weight since baseline	1 year	No
Secondary	Diabetes	change in HBA1c from baseline	1 year	No
Secondary	renal dysfunction	change in estimated glomerular filtration rate	1 year	No