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Lifestyle Intervention For Liver Transplantation (LIFT)

Primary Purpose

Liver Disease

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Behavioural intervention
Sponsored by
Newcastle-upon-Tyne Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Liver Disease focused on measuring transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept of perioperative and critical care medicine, Freeman Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

liver transplant patients

Arm Description

Patients will use a behavioural intervention to assess its usability

Outcomes

Primary Outcome Measures

Feasibility testing of the intervention
Qualitative assessment of the behavioural intervention by focus groups and interviews with patients and healthcare professionals

Secondary Outcome Measures

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

Full Information

First Posted
October 12, 2015
Last Updated
March 1, 2016
Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02696655
Brief Title
Lifestyle Intervention For Liver Transplantation
Acronym
LIFT
Official Title
Development and Feasibility Testing of a Behavioural Intervention Targeting Multiple Lifestyle Behaviours to Improve Long Term Outcomes Following Liver Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Disease
Keywords
transplantation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
liver transplant patients
Arm Type
Experimental
Arm Description
Patients will use a behavioural intervention to assess its usability
Intervention Type
Behavioral
Intervention Name(s)
Behavioural intervention
Intervention Description
Behavioural intervention administered by healthcare professionals targetting multiple lifestyle behaviours
Primary Outcome Measure Information:
Title
Feasibility testing of the intervention
Description
Qualitative assessment of the behavioural intervention by focus groups and interviews with patients and healthcare professionals
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Exercise capacity
Description
Assessed by pedometers (average steps per day taken assessed over one week)
Time Frame
1 year
Title
Hypertension
Description
Change in blood pressure from baseline
Time Frame
1 year
Title
Weight
Description
change in weight since baseline
Time Frame
1 year
Title
Diabetes
Description
change in HBA1c from baseline
Time Frame
1 year
Title
renal dysfunction
Description
change in estimated glomerular filtration rate
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Prentis, MBBS
Phone
01912336161
Ext
48684
Email
james.prentis@nuth.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leah Avery
Organizational Affiliation
Newcastle University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of perioperative and critical care medicine, Freeman Hospital
City
Newcastle upon tyne
State/Province
Tyne and Wear
ZIP/Postal Code
NE77DN
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24480518
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.
Results Reference
result
PubMed Identifier
22521347
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 years from the ELTR database. J Hepatol. 2012 Aug;57(2):288-96. doi: 10.1016/j.jhep.2012.03.017. Epub 2012 Apr 18.
Results Reference
result
PubMed Identifier
18031464
Citation
Pfitzmann R, Nussler NC, Hippler-Benscheidt M, Neuhaus R, Neuhaus P. Long-term results after liver transplantation. Transpl Int. 2008 Mar;21(3):234-46. doi: 10.1111/j.1432-2277.2007.00596.x. Epub 2007 Nov 21.
Results Reference
result
PubMed Identifier
12149596
Citation
Benhamou PY, Penfornis A. Natural history, prognosis, and management of transplantation-induced diabetes mellitus. Diabetes Metab. 2002 Jun;28(3):166-75.
Results Reference
result
PubMed Identifier
9346772
Citation
Gisbert C, Prieto M, Berenguer M, Breto 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. doi: 10.1002/lt.500030409.
Results Reference
result
PubMed Identifier
25830307
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.
Results Reference
result

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Lifestyle Intervention For Liver Transplantation

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