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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05658393
Other study ID # Akdeniz U
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date October 9, 2023

Study information

Verified date August 2023
Source Akdeniz University
Contact Ferya CELIK, MSc
Phone +90 545 641 29 10
Email feryacelik@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
ReLiver-N App
Web-based mobile health application for patients with liver cirrhosis

Locations

Country Name City State
Turkey Akdeniz University Antalya

Sponsors (1)

Lead Sponsor Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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