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Completed

NCT Number: NCT06995196

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

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 consisted of 48 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akdeniz University

Antalya, 07070, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ReLiver-N App

Behavioral

Intervention for intervention group: Patients will access all content of ReLiver-N App. The ReLiver-N App 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.

Other names: Intervention for active control gorups: Patients in the active control groups will access only health education content of ReLiver-N App

Primary outcomes

  1. Patient Activation-Patient Activation Measure

    Time frame: 12 weeks

    The Patient Activation Measure (PAM) is a 13-item measure that assesses patient knowledge, skill, and confidence for self-management. The higher score showes better outcome.

  2. Self-efficacy, Self-efficacy for Managing Chronic Disease 6-item Scale

    Time frame: 12 weeks

    This 6-item scale contains items taken from several SE scales developed for the Chronic Disease Self Management study. The higher score showes better outcome.

  3. Quality of life - Chronic Liver Disease Questionnaire

    Time frame: 12 weeks

    The CLDQ includes 29 items in the following domains: abdominal symptoms, fatigue, systemic symptoms, activity, emotional function and worry. The higher score showes better outcome.

Secondary outcomes

  1. Hospital readmissin

    Time frame: 12 weeks

    Hospital readmissions frequently occur in patients with cirrhosis and are associated with liver disease severity.

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study 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

Acronym: ReLiver-NApp

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 29, 2025
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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