NCT02696655

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

March 2, 2016

Status Verified

February 1, 2016

Enrollment Period

1.8 years

First QC Date

October 12, 2015

Last Update Submit

March 1, 2016

Conditions

Liver Disease

Keywords

transplantation

Outcome Measures

Primary Outcomes (1)

  • Feasibility testing of the intervention

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

    1 year

Secondary Outcomes (5)

  • Exercise capacity

    1 year

  • Hypertension

    1 year

  • Weight

    1 year

  • Diabetes

    1 year

  • renal dysfunction

    1 year

Study Arms (1)

liver transplant patients

EXPERIMENTAL

Patients will use a behavioural intervention to assess its usability

Behavioral: Behavioural intervention

Interventions

Behavioural interventionBEHAVIORAL

Behavioural intervention administered by healthcare professionals targetting multiple lifestyle behaviours

liver transplant patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of perioperative and critical care medicine, Freeman Hospital

Newcastle upon Tyne, Tyne and Wear, NE77DN, United Kingdom

Location

Related Publications (6)

  • 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.

    PMID: 24480518RESULT

  • 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.

    PMID: 22521347RESULT

  • 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.

    PMID: 18031464RESULT

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

    PMID: 12149596RESULT

  • 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.

    PMID: 9346772RESULT

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

    PMID: 25830307RESULT

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Leah Avery

    Newcastle University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

James Prentis, MBBS

CONTACT

01912336161james.prentis@nuth.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2015

First Posted

March 2, 2016

Study Start

February 1, 2016

Primary Completion

November 1, 2017

Study Completion

February 1, 2018

Last Updated

March 2, 2016

Record last verified: 2016-02

Locations

GB(1)