Clinical trial NCT06995196: Care Algorithm and Clinic Decision System on Hepatic Rehabilitation in Patients With Liver Cirrhosis
Official title: The Effect of the Use of ReLiver-N App Developed for Patients With Liver Cirrhosis on Hepatic Rehabilitation: A Randomized Controlled Single-Blind Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Cirrhosis
Keywords: nursing care
hepatic rehabilitation
care algorithm
patient activation
patient clinic decision system
liver cirrhosis
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Activation-Patient Activation Measure
timeFrame: 12 weeks
measure: Self-efficacy, Self-efficacy for Managing Chronic Disease 6-item Scale
timeFrame: 12 weeks
measure: Quality of life - Chronic Liver Disease Questionnaire
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
References: