Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/01/2015
Date assigned
28/01/2015
Last edited
15/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr James Orr

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17803

Study information

Scientific title

Home Monitoring in Encephalopathy: a randomised controlled trial

Acronym

The d-LIVER HoME trial

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

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 measures

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

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

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

15/08/2017: Plain English summary added. No publications found, verifying study status with principal investigator.