Web-based Mobile Health Application for Patients With Liver Cirrhosis (ReLiver-N App)

NCT05658393 | Completed DMC

• 1 other identifier: Akdeniz U
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effect of a web-based mobile health application for patients with liver cirrhosis (ReLiver-N App) developed for enhancing patients' activation on the level of patient activation, self-efficacy, and quality of life. To manage liver cirrhosis after discharge, patients must continue to do some interventions at home like weight measurement, edema evaluation, and taking medications. To achieve this, the patient's activation level should be enhanced and that can contribute to hepatic rehabilitation. It would be beneficial to develop a web-based mobile health application for patients with liver cirrhosis that can enhance patient activation levels. The investigators developed the ReLiver-N App based ADDIE which is instructional design framework and created its contents of it. Our content includes about us, patient education information about liver cirrhosis, patient activity skills and measuring tools. Ten 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. A single-blind randomized controlled trial design will be applied. Patients with liver cirrhosis will be pretested and randomized (intervention (ReLiver-N App): 26, active control: 26) to the ReLiver-N App group and active control group. Both the ReLiver-N App group and active control group will use the ReLiver-N App for three months. While participants in the ReLiver-N group can reach all content of the ReLiver-N App. Participants in the active control group will have access to "about us", "patient activity skills", and "measuring tools" in the ReLiver-N App. Patient education information about liver cirrhosis will be encrypted.

Conditions

Mobile Health; Liver Cirrhosis; Patient Activation

Keywords

liver cirrhosis; mobile health; Patient Activation

Outcome Measures

Primary Outcomes (3)

• Patient Activation Measure (PAM)

  The Patient Activation Measure (PAM) gauges a patient's level of belief, knowledge, skill, and self-assurance. 13 components make up the Patient Activation Measure. Patients are actively/successfully managing their disease when they receive higher scores on the scale. Each response option has a 4-point Likert scale with the options ranging from totally disagree to totally agree and 'non-applicable.' Scores for activities range from 0 to 100. Level 1, the lowest activity with a score of 47, deals with the idea that playing an active part is important. Level 2, which ranges from 47 to 55, denotes knowledge and the capacity for action. Level 3, which ranges from 55 to 72, deals with action. The highest activity, Level 4, with scores of \>72.5, is keeping to a schedule even when under stress. Cronbach's alpha value of the original scale was determined as 0.88.

  Change from baseline PAM at one month, Change from baseline PAM at two months, Change from baseline PAM at three months

• Self-Efficacy for Managing Chronic Disease 6-Item Scale (SEMCD6IS)

  The scale is scored on a scale of 1 to 10, with 1 being "not at all confident" and 10 being "totally confident." High scores on the scale denote high self-efficacy. The scale's score is the average of the six components. The lower score is taken into account in the computation if there are several responses to a question and the items are consecutive. This item is not included in the calculation if the two answers provided are not sequential. There must be at least 4 responses for the scale to be calculated. Cronbach's alpha value of the original scale was determined as 0.88.

  Change from baseline SEMCD6IS at one month, Change from baseline SEMCD6IS at two months, Change from baseline SEMCD6IS at three months

• Chronic Liver Disease Questionnaire (CLDQ)

  The Chronic Liver Disease Questionnaire (CLDQ) is a 29-item self-report questionnaire, consisting of six subdimension, which include abdominal symptoms, fatigue, systemic symptoms, activity, emotional function, and anxiety. All items ask for the symptoms during the previous two weeks. The overall ICC value of the original CLDQ is 0.59.

  Change from baseline CLDQ at one month, Change from baseline CLDQ at two months, Change from baseline CLDQ at three months

Study Arms (2)

ReLiver-N App Group

EXPERIMENTAL

The ReLiver-N App will be introduced to the participants with liver cirrhosis during face-to-face interviews. The ReLiver-N App group will have access to all the contents of the ReLiver-N App, which includes the "about us", "patient education information about liver cirrhosis ", "patient activity skills", and "measuring tools". During the follow-up period, the participants in the ReLiver-N App group will take WhatsApp messages once a week and be reminded to use the education program. The ReLiver-N App will be asked to use it for three months on daily and weekly inputs their results. During the follow-up period, the participants can contact researcher via the 24/7 on the ReLiver-N App. The clinical researchers of the team will answer the participant' questions via WhatsApp. Participants in the ReLiver-N group will also receive routine patient education and routine hospital follow-ups given by the Gastroenterology team.

Behavioral: ReLiver-N App

Active Control Group

ACTIVE COMPARATOR

The ReLiver-N App will be introduced to the participants with liver cirrhosis in the active control group during face-to-face interviews. The active control group will have access to only these fields "about us", "patient activity skills", and "measuring tools". Participants in the active control group will also receive routine patient education and routine hospital follow-ups given by the Gastroenterology team during the three-month follow-up period.

Behavioral: ReLiver-N App

Interventions

ReLiver-N App BEHAVIORAL

Web-based mobile health application for patients with liver cirrhosis

Active Control Group; ReLiver-N App Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with liver cirrhosis
• Had Child-Pugh A and B categories
• 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, 07070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Liver Cirrhosis; Patient Participation

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be divided into groups according to the randomization list created to assign each patient to a group. Two independent researchers will conduct the assignment of participants to the ReLiver-N App and active control groups and the evaluation of outcome measurement data. Researchers will not be blinded as they make these interventions. However, participants will be blinded because they do not know which group, they are in.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 20, 2022
• Study Start: October 1, 2022
• Primary Completion: May 30, 2023
• Study Completion: July 9, 2023
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

TU (1)