Lifestyle Intervention For Liver Transplantation (LIFT)

March 1, 2016 updated by: Newcastle-upon-Tyne Hospitals NHS Trust

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

(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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • Tyne and Wear
      • Newcastle upon tyne, Tyne and Wear, United Kingdom, NE77DN
        • Dept of perioperative and critical care medicine, Freeman Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: liver transplant patients
Patients will use a behavioural intervention to assess its usability
Behavioral: Behavioural intervention
Behavioural intervention administered by healthcare professionals targetting multiple lifestyle behaviours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility testing of the intervention
Time Frame: 1 year
Qualitative assessment of the behavioural intervention by focus groups and interviews with patients and healthcare professionals
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Investigators

  • Principal Investigator: Leah Avery, Newcastle University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

October 12, 2015

First Submitted That Met QC Criteria

March 1, 2016

First Posted (Estimate)

March 2, 2016

Study Record Updates

Last Update Posted (Estimate)

March 2, 2016

Last Update Submitted That Met QC Criteria

March 1, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7526

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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