ISRCTN ISRCTN10363786
DOI https://doi.org/10.1186/ISRCTN10363786
IRAS number 156104
Secondary identifying numbers 17803, IRAS 156104
Submission date
28/01/2015
Registration date
28/01/2015
Last edited
02/09/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Hepatic encephalopathy (HE) is a complication of advanced liver disease. It happens when the liver is not able to break down toxins from the bowel which then enter the blood stream and travel to the brain. It can cause the patient to become confused and lead to a reduced level of consciousness. HE often results in emergency admission to hospital and can result in reduced quality of life. The first-line treatment of HE is the laxative lactulose which increases stool frequency and reduces absorption of toxins produced by bacteria in the gut. However, in spite of this treatment, HE often worsens, leading to readmission into hospital. One potential contributing factor is that large doses of lactulose can be unpleasant for patients to take, meaning that they are less likely to take it, particularly when there appears to be no evidence of ongoing confusion. The aim of this study is to investigate the use of a home monitoring system to direct lactulose treatment in patients who have had a previous episode of HE.

Who can participate?
Patients aged 18-80 with advanced liver disease who have had a previous episode of HE

What does the study involve?
Participants take a simple cognitive (thinking) test on a daily basis and they record their stool frequency using a tablet PC. This information is used to adjust lactulose dose
where appropriate. In situations where there is evidence of increasing confusion which is not responding to treatment, a clinician intervenes.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University of Newcastle upon Tyne (UK)

When is the study starting and how long is it expected to run for?
November 2014 to July 2015

Who is funding the study?
1. European Commission Information Society and Media Directorate General
2. National Institute for Health Research (UK)

Who is the main contact?
Dr James Orr

Contact information

Dr James Orr
Scientific

University of Newcastle upon Tyne
Institute of Cellular Medicine
Claremont Road
Newcastle Upon Tyne
NE1 7RU
United Kingdom

Study information

Study designRandomised; Interventional; Design type: Treatment
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Home
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleHome Monitoring in Encephalopathy: a randomised controlled trial
Study acronymd-LIVER HoME
Study objectivesThis pilot evaluation aims to investigate the use of a home monitoring system to direct lactulose therapy in patients with a previous episode of overt hepatic encephalopathy.
Ethics approval(s)Approved 29/09/2014, North East - Newcastle & North Tyneside 1 Research Ethics Committee, REC ref: 14/NE/1114
Health condition(s) or problem(s) studiedTopic: Gastroenterology, Hepatology; Subtopic: Hepatology, Gastroenterology; Disease: All Gastroenterology, All Hepatology
InterventionElectronic home monitoring: Using a tablet PC, patients will carry out a cognitive test and a health enquiry on a daily basis. Based on this treatment for hepatic encephalopathy will be optimised.
Follow Up Length: 6 month(s)
Intervention typeBehavioural
Primary outcome measurePatient acceptability; Timepoint(s): 8 weeks, 16 weeks, 24 weeks
Secondary outcome measures1. Admission rates; Timepoint(s): throughout study
2. Completion rate; Timepoint(s): throughout trial
3. Health related quality of life; Timepoint(s): 8 weeks, 16 weeks, 24 weeks
4. Healthcare resource utilisation; Timepoint(s): 8 weeks, 16 weeks 24 weeks
5. Rate of change of therapy; Timepoint(s): throughout study
Overall study start date17/11/2014
Completion date31/07/2015

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit80 Years
SexBoth
Target number of participantsPlanned Sample Size: 20; UK Sample Size: 20
Key inclusion criteria1. Age 18-80 years
2. Patient has capacity and provided written informed consent for participation in the study prior to any study specific procedures
3. Cirrhosis defined either histologically on liver biopsy OR clinically by 2 of:
3.1. Imaging suggestive of cirrhosis (irregular outline and/or spleen >12cm)
3.2. Fibroscan >17.6kPa
3.3. Oesophageal or gastric varices or portal hypertensive gastropathy
3.4. Platelets <120
3.5. Ascites
3.6. Encephalopathy
4. Inpatient at Freeman Hospital, Newcastle or Royal Victoria Infirmary, Newcastle due to overt hepatic encephalopathy (OHE), treated with lactulose
Key exclusion criteria1. Age <18 or >80
2. Unable to provide informed consent
3. Unable to understand written English
4. Malignancy (including HCC)
5. Participating in another interventional study
6. Previous participation in this study
Date of first enrolment17/11/2014
Date of final enrolment31/07/2015

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Newcastle upon Tyne
Institute of Cellular Medicine
Claremont Road
Newcastle Upon Tyne
NE1 7RU
United Kingdom

Sponsor information

Newcastle upon Tyne Hospitals NHS Foundation Trust
Hospital/treatment centre

Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
England
United Kingdom

ROR logo "ROR" https://ror.org/05p40t847

Funders

Funder type

Government

European Commission Information Society and Media Directorate General

No information available

National Institute for Health Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration

2015 abstract in https://doi.org/10.1016/S0168-8278(15)31503-8 (added 02/09/2020)
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No

Editorial Notes

02/09/2020: Abstract, IRAS Project ID and ethics approval details added.
15/08/2017: Plain English summary added. No publications found, verifying study status with principal investigator.