Home monitoring in encephalopathy
| 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
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
Scientific
University of Newcastle upon Tyne
Institute of Cellular Medicine
Claremont Road
Newcastle Upon Tyne
NE1 7RU
United Kingdom
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Home Monitoring in Encephalopathy: a randomised controlled trial |
| Study acronym | d-LIVER HoME |
| Study objectives | 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(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) studied | 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 |
| 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 study start date | 17/11/2014 |
| Completion date | 31/07/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 20; UK Sample Size: 20 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 17/11/2014 |
| Date of final enrolment | 31/07/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Claremont Road
Newcastle Upon Tyne
NE1 7RU
United Kingdom
Sponsor information
Hospital/treatment centre
Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
England
United Kingdom
"ROR" |
https://ror.org/05p40t847 |
|---|
Funders
Funder type
Government
No information available
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| 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) |
| 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.
