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Home monitoring in encephalopathy

Home Monitoring in Encephalopathy: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10363786
Enrollment
20
Registered
2015-01-28
Start date
2014-11-17
Completion date
Unknown
Last updated
2020-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Gastroenterology, Hepatology

Interventions

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.

Sponsors

Newcastle upon Tyne Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Age 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

Design outcomes

Primary

MeasureTime frame
Patient acceptability; Timepoint(s): 8 weeks, 16 weeks, 24 weeks

Secondary

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026