The Effect of the Use of ReLiver-N App Developed for Patients With Liver Cirrhosis on Hepatic Rehabilitation: A Randomized Controlled Single-Blind Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Turkey
Akdeniz University
RECRUITING
Antalya
Contact Information
Primary
Ferya Celik, PhD
feryacelik@gmail.com
+90 242 226 13 58
Backup
Hicran Bektas, Professor Dr
hbaydin@akdeniz.edu.tr
+90 242 226 13 58
Time Frame
Start Date: 2025-01-20
Estimated Completion Date: 2025-10-01
Participants
Target number of participants: 48
Treatments
Experimental: Intervention
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.
Active_comparator: Active Control
Patients in the active control group access only education content of ReLiver-N App and patient activation intervention without feedback of their results.
Related Therapeutic Areas
Sponsors
Leads: Akdeniz University

This content was sourced from clinicaltrials.gov