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
Other
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 table 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
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