Liver Disease Clinical Trial
— LIFTOfficial 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
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United Kingdom | Dept of perioperative and critical care medicine, Freeman Hospital | Newcastle upon tyne | Tyne and Wear |
Lead Sponsor | Collaborator |
---|---|
Newcastle-upon-Tyne Hospitals NHS Trust |
United Kingdom,
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
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 |
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