Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
17803, IRAS 156104
Study information
Scientific title
Home Monitoring in Encephalopathy: a randomised controlled trial
Acronym
d-LIVER HoME
Study hypothesis
This 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
Approved 29/09/2014, North East - Newcastle & North Tyneside 1 Research Ethics Committee, REC ref: 14/NE/1114
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Home
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Gastroenterology, Hepatology; Subtopic: Hepatology, Gastroenterology; Disease: All Gastroenterology, All Hepatology
Intervention
Electronic 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 type
Behavioural
Phase
Drug names
Primary outcome measure
Patient acceptability; Timepoint(s): 8 weeks, 16 weeks, 24 weeks
Secondary outcome measures
1. 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 trial start date
17/11/2014
Overall trial end date
31/07/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 20; UK Sample Size: 20
Participant exclusion criteria
1. 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
Recruitment start date
17/11/2014
Recruitment end date
31/07/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Newcastle upon Tyne
Institute of Cellular Medicine
Claremont Road
Newcastle Upon Tyne
NE1 7RU
United Kingdom
Funders
Funder type
Government
Funder name
European Commission Information Society and Media Directorate General
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
2015 abstract in https://doi.org/10.1016/S0168-8278(15)31503-8 (added 02/09/2020)
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list