Care Algorithm and Clinic Decision System on Hepatic Rehabilitation in Patients With Liver Cirrhosis

Not Applicable

Recruiting

• Conditions: Liver Cirrhosis

• Registration Number: NCT06995196
• Lead Sponsor: Akdeniz University

Brief Summary

Liver cirrhosis is an important public health problem that causes morbidity and mortality. In order to provide hepatic rehabilitation of patients with liver cirrhosis, interventions that provide active care practices by patients and evaluation of results are needed. In this trial, it is aimed to develop a nurse-led mobile health application (ReLiver-N App- Rehabilitation of Liver by Nurse), which has comprehensive health education, patient activation practices, care algorithm, and clinical decision system, to provide and maintain the hepatic rehabilitation of patients with liver cirrhosis and to evaluate the effect of the use of ReLiver-N App on hepatic rehabilitation. Care algorithm and clinical decision system will be evaluated results of patient activation as "normal", "controllable", "urgent". Feedbacks will be sent to patients based on the evaluations. This project consists of two phases, methodological and randomized controlled experimental study. The first stage, in which ReLiver-N App will be developed, is planned as a methodological study, and the second stage, in which the effect of ReLiver-N App on hepatic rehabilitation will be evaluated, as a randomized controlled single-blind experimental study. ReLiver-N App will be developed in line with the steps of the Design Based Research Model. The sample size of the project is planned to consist of 56 patients with liver cirrhosis. Patients with a diagnosis of liver cirrhosis, 18 years of age and older, with the severity of the disease in Child Pugh A and B categories, without verbal or written communication barriers, with a smart phone, and who consented to participate in the study will constitute the sample. Pre-tests will be applied by face-to-face interview method. Assignment of patients to intervention and control groups will be made by block randomization. While patients in the intervention group access all the content of ReLiver-N App; patients in the control group will not have access to any data on the intervention. It is planned that the project will be implemented for 90 days and follow up evaluations will be made every month. Follow up assessments and post-test data will be available online via the ReLiver-N App. The dependent variable of the project is hepatic rehabilitation, and the independent variable is ReLiver-N Intervention Protocol.

Detailed Description

Liver cirrhosis, a progressive, chronic disease characterized by fibrotic tissue, regenerative nodules, and loss of function in liver cells, is an important public health problem that causes morbidity and mortality. The European Association for the Study of the Liver (EASL) recommends providing appropriate treatment and care at an early stage, preventing the development of complications, and early recovery in order to reduce morbidity and mortality due to liver cirrhosis. In line with this recommendation, treatment and care practices in patients with liver cirrhosis should be planned to prevent the development and recurrence of life-threatening symptoms and to help improve them. It is stated that hepatic rehabilitation programs to be developed for patients with liver cirrhosis are an important part of achieving this goal. Hepatic rehabilitation includes practices carried out to maintain and improve the health of hospitalized or discharged liver cirrhosis patients, to ensure the active participation of patients in self-care practices, to prevent and improve complications, and to provide palliative care when necessary. Hepatic rehabilitation programs that patients can access continuously, use as a source of information about their diseases, learn and apply care practices, and receive instant feedback in line with real-time health data are needed for hepatic rehabilitation. In this trial, the ReLiver-N Intervention Protocol was created to provide hepatic rehabilitation for patients diagnosed with liver cirrhosis. The content of the ReLiver-N Intervention Protocol consists of comprehensive health education, patient activity practices (daily patient activity practices: medication use, weight monitoring, edema monitoring, intake-exit monitoring, defecation monitoring; weekly patient activity practices: fever, blood pressure, pulse measurement), care algorithms, and patient decision support system. The ReLiver-N Intervention Protocol is being developed within the scope of the Design-Based Research Method.

Study Timeline

• Study Start: 2025-01-10
• Status Verified: 2025-05
• Study First Submitted: 2025-05-13
• Study First Submitted QC: 2025-05-27
• Last Update Submitted: 2025-05-27
• Study First Posted: 2025-05-29
• Last Update Posted: 2025-05-29
• Primary Completion: 2025-07-09
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Diagnosed with liver cirrhosis Had Child-Pugh A and B categories 18 years of age or older No barriers to verbal or written communication Having internet at home and a smartphone Patients who consented to participate in the study.

Exclusion Criteria

Had Child-Pugh C category Had pregnant Liver transplanted Diagnosed with hepatocellular carcinoma Having dementia Having been diagnosed with a psychiatric disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient Activation-Patient Activation Measure	12 weeks
Self-efficacy, Self-efficacy for Managing Chronic Disease 6-item Scale	12 weeks
Quality of life - Chronic Liver Disease Questionnaire	12 weeks

Trial Locations

Locations (1)

Akdeniz University; 🇹🇷 Antalya, Turkey