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

NCT06995196 | Completed

• 2 other identifiers: TÜBİTAK 123S032123S032
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Liver Cirrhosis

Keywords

nursing care; hepatic rehabilitation; care algorithm; patient activation; patient clinic decision system; liver cirrhosis

Outcome Measures

Primary Outcomes (3)

• Patient Activation-Patient Activation Measure

  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.

  12 weeks

• Self-efficacy, Self-efficacy for Managing Chronic Disease 6-item Scale

  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.

  12 weeks

• Quality of life - Chronic Liver Disease Questionnaire

  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.

  12 weeks

Secondary Outcomes (1)

• Hospital readmissin

  12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Patients in the intervention group access all the content of ReLiver-N App incluiding educational content, patient activation intervensions, care algorithms, and patient clinical decision systems.

Behavioral: ReLiver-N App

Active Control

ACTIVE COMPARATOR

Patients in the active control group access only education content of ReLiver-N App and patient activation intervention without feedback of their results.

Behavioral: ReLiver-N App

Interventions

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.

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

Active Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University

Antalya, Antalya, 07070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Liver Cirrhosis; Patient Participation

Interventions

Methods

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Ferya Celik, PhD

  Akdeniz University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Dr

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 29, 2025
• Study Start: October 1, 2023
• Primary Completion: July 9, 2025
• Study Completion: August 1, 2025
• Last Updated: February 20, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2 years after the article was published
• Access Criteria: It could be shared on demand

Locations

TU (1)