Non-alcoholic fatty liver disease (NAFLD) Digestive System
Conditions
Interventions
Patients will be given a personal login for the VITALISE programme and will have continuous access for a 6-month time period prior to their follow-up appointment with a hepatologist. Patients will be
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and over 2. Clinical diagnosis of NAFLD following review by a hepatologist within the last 6 months 3. Willing and able to give written informed consent
Exclusion criteria
Exclusion criteria: 1. Decompensated NASH cirrhosis (Child Pugh score = 7) 2. Diagnosed/previous eating disorder or purging 3. Excessive alcohol consumption (>14 units/week for females; >21 units/week for males) 4. Known cancer (except skin cancer) 5. Myocardial infarction within 6 months or uncontrolled cardiovascular disease 6. Pregnant/considering pregnancy 7. Inability to understand written and verbal English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Criteria used to judge the feasibility of progressing to a larger scale evaluation: 1. Total number of patients recruited per month measured using data from a screening log over 6 months 2. Percentage of recruited patients who log in measured using data from the VITALISE digital platform during their 6-month intervention 3. Percentage of patients who logged in to VITALISE and provide follow-up data logged during the follow-up visit at 6 months These criteria aim to retain a sufficient sample size to determine acceptability and feasibility. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine whether acceptability and feasibility lead to changes in clinical outcomes, including: 1. Body weight 2. HbA1C 3. Liver enzymes 4. Liver stiffness 5. Blood pressure 6. Lipid profile All measured as part of standard care using standard methods at baseline and 6 months | — |
Countries
England, United Kingdom
Outcome results
None listed