Liver DiseaseLIFTNCT02696655
Lifestyle Intervention For Liver Transplantation
A study testing Behavioural intervention in people with Liver Disease, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Disease
- What is being tested?
- Behavioural intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2016to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Dept of perioperative and critical care medicine, Freeman Hospital
Newcastle upon Tyne, Tyne and Wear, NE77DN
About this study
Official title: 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
Read the 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
- Conditions
- Liver Disease
- Being tested
- Behavioural intervention
- Keywords
- transplantation
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioural interventionBehavioural
Behavioural intervention administered by healthcare professionals targetting multiple lifestyle behaviours
| Study group | Role | What they receive |
|---|---|---|
| liver transplant patients | Experimental | Patients will use a behavioural intervention to assess its usability Receives: Behavioral: Behavioural intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility testing of the intervention
Qualitative assessment of the behavioural intervention by focus groups and interviews with patients and healthcare professionals
Measured: 1 year
Secondary outcomes (5)
Exercise capacity
Assessed by pedometers (average steps per day taken assessed over one week)
Measured: 1 year
Hypertension
Change in blood pressure from baseline
Measured: 1 year
Weight
change in weight since baseline
Measured: 1 year
Diabetes
change in HBA1c from baseline
Measured: 1 year
renal dysfunction
change in estimated glomerular filtration rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionNov 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leah Avery, Principal investigator, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696655
- Sponsor's protocol ID
- 7526
- Acronym
- LIFT
- Status last verified
- Feb 2016
- First submitted
- 12 Oct 2015
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24480518Germani 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.
PubMed 22521347Pfitzmann 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.
PubMed 18031464Benhamou PY, Penfornis A. Natural history, prognosis, and management of transplantation-induced diabetes mellitus. Diabetes Metab. 2002 Jun;28(3):166-75.
PubMed 12149596Gisbert 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.
PubMed 9346772Luca L, Westbrook R, Tsochatzis EA. Metabolic and cardiovascular complications in the liver transplant recipient. Ann Gastroenterol. 2015 Apr-Jun;28(2):183-192.
PubMed 25830307
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Feasibility Testing of a Behavioural Intervention Targeting Multiple Lifestyle Behaviours to Improve Long Term Outcomes Following Liver Transplantation
- ClinicalTrials.gov ID
- NCT02696655
- Acronym / sponsor ID
- LIFT / 7526
- Conditions
- Liver Disease
- Keywords
- transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 2 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
(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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liver transplant patients | Experimental | Behavioral: Behavioural interventionPatients will use a behavioural intervention to assess its usability |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioural interventionBehavioural intervention administered by healthcare professionals targetting multiple lifestyle behaviours | Behavioural | liver transplant patients |
Primary outcome
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
5 secondary outcomes
Exercise capacity
Time frame: 1 year
Hypertension
Time frame: 1 year
Weight
Time frame: 1 year
Diabetes
Time frame: 1 year
renal dysfunction
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
- Results publication: PubMed 24480518Tsochatzis 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 publication: PubMed 22521347Germani 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 publication: PubMed 18031464Pfitzmann 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 publication: PubMed 12149596Benhamou PY, Penfornis A. Natural history, prognosis, and management of transplantation-induced diabetes mellitus. Diabetes Metab. 2002 Jun;28(3):166-75.
- Results publication: PubMed 9346772Gisbert 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 publication: PubMed 25830307Luca L, Westbrook R, Tsochatzis EA. Metabolic and cardiovascular complications in the liver transplant recipient. Ann Gastroenterol. 2015 Apr-Jun;28(2):183-192.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leah Avery principal investigator
Newcastle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioural intervention in people with Liver Disease, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Prentis, MBBS (01912336161 ext. 48684, james.prentis@nuth.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility testing of the intervention (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02696655, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2016.