The Effect of a Mobile Health Application Developed for Patients With Liver Cirrhosis on Patient Activation, Self-Efficacy, and Quality of Life

Liver cirrhosis is an important health problem that leads to morbidity and mortality. To maintain symptom management after discharge, patient education and activation should be enhanced. The unmet educational needs of patients with liver cirrhosis cause ineffective management of liver cirrhosis. It is important for patients to actively participate in patient activation practices and develop their skills. Patient activation practices, which are the responsibility of the patient in the management of liver cirrhosis, are easy to apply and provide effective results. Improving patient activation could help with early symptom detection and control of symptoms, and that can contribute to hepatic rehabilitation. It seems that using accessible and sustainable mobile health applications could help provide patient education and enhance activation. Mobile health applications make it possible to enable patients to provide information to enhance their level of activation. Mobile health applications developed for patient activation could help patients learn their responsibilities for health and be motivated to do them. When the level of patient activation gets higher, patients' self-efficacy and quality of life getting higher. The study evaluates the effect of the web-based mobile health application (ReLiver-N App) developed for patient activation in patients with liver cirrhosis on patient activation, self-efficacy, and quality of life.

Objective: It is aimed to develop a web-based mobile health application (ReLiver-N App) for patients with liver cirrhosis and to evaluate the effect of ReLiver-N App use on patients' activation, self-efficacy, and quality of life. The ReLiver-N App engages and supports patients with liver cirrhosis by increasing patient activation through m-health education. This could increase patient activation, self-efficacy, and quality of life. This study primarily aims the analysis the efficacy of ReLiver-N App on increasing patient activation, self-efficacy, and quality of life.

Method: The first stage of this study was the development stage of the ReLiver-N App based ADDIE which is instructional design framework. This stage included reading the content and designing the ReLiver-N App. The content of the ReLiver-N App was based on the needs of patients, evidence, and recommendations for patient education in liver cirrhosis such as guidelines, meta-analyses, randomized controlled trials, reliable patient education websites, and expert opinions. The investigators created the contents of the ReLiver-N App. Our content includes "about us", "patient education information about liver cirrhosis ", "patient activity skills", and "measuring tools". Patient education information topics include a healthy lifestyle, let's learn about liver cirrhosis, complications of liver cirrhosis, diagnosis, treatment methods, and let's enhance quality of life and self-efficacy. Patient activity skills are divided into two groups: daily activity skills and weekly activity skills. Daily activity skills include weight measurement, edema evaluation, and taking medications. Weekly activity skills include taking blood pressure, heart rate, and body temperature. Measurements questionnaires include pre-test, follow-up and end-point questionnaires. The participants can answer these questionnaire via ReLiver-N App. After preparing the content, 10 experts evaluated the quality of the content and the investigators conducted a feasibility test with three patients to assess the usability of the ReLiver-N App group.

In the second stage, the investigators will conduct a single-blind randomized controlled study to determine the effect of the ReLiver-N App developed for patients with liver cirrhosis on patient activation, self-efficacy, and quality of life. This study will be conducted in patients with liver cirrhosis who are followed up and treated in the Gastroenterology Outpatient Clinic and Inpatient Clinic and meets the inclusion criteria of the sample. In this study, the sample size was calculated based on 80% power and a 5% confidence interval on the G*POWER software package. The study will be conducted in patients with liver cirrhosis (n=52), 26 in the ReLiver-N App group and 26 in the control group. The patients who had been diagnosed with liver cirrhosis, were over 18 years of age, literate, had Child-Pugh Score A and B, had internet at home and a smartphone, consented to participate in the study and had no other psychiatric or emotional problems, language or cognitive difficulties, and barriers to verbal or written communication were included. It will be prepared in line with the Consolidated Standard of Reporting Trials - CONSORT 2018 guidelines. There will be a screening, pre-test at baseline, randomization, and follow-up.

Full sociodemographic, and clinical assessments and obtained consent will be carried out at the screening. At the screening stage, all participants will be informed about ReLiver-N App and this study face-to-face at the hospital first. After that participants could be used ReLiver-N App at home. The pre-test will be carried out baseline measurement. After baseline measurements will be undertaken by the researcher before randomization takes place.