The Effect of Education on Drug Compliance and Quality of Life in Hepatitis B Patients

Quality of Life Clinical Trial

Official title:

The Effect of Education on Oral Antiviral Use on Medication Compliance and Quality of Life in Patients With Hepatitis-B Diagnosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05286216
• Other study ID #: Sengul Korkmaz Binay Tez
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 15, 2022
• Est. completion date: December 25, 2022

Study information

• Verified date: March 2022
• Source: Istanbul University-Cerrahpasa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to determine the effect of the education given to patients with CHB who use oral antiviral drugs on oral antiviral drug use on drug compliance and quality of life.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 25, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Being diagnosed with CHB for at least 6 months,

• To be over 18 years old,

• Using oral antiviral treatment for at least three months,

• To be a literate person,

• No malignancy other than hepatocellular carcinoma,

• Not having vision and hearing problems,

• Not having cognitive or psychiatric problems,

• Patients/patient relatives who can use smartphones (In order to invite the patients to the 3rd and 6th month controls and to inform and remind the experimental group about the training time, they / their relatives should have and can use a mobile phone)

• Volunteer to participate in the study.

Exclusion Criteria:

• •Continuing to use alcohol after the first evaluation,

• Not willing to participate in the study,

• Patients with a psychiatric diagnosis,

• Patients who do not meet the sample inclusion criteria.

Related Conditions & MeSH terms

• Adherence, Medication
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Quality of Life

Intervention

Behavioral:
• effectiveness of education
The education program will be prepared using power point presentations within the relevant scientific literature. The education program is planned to be given to each group as 1 session on 2 different days, between 09:30 and 13:00. Day 1 module 1; Module 2 will be shared on the 2nd day and all patients in the experimental group will participate in the education program. During and after the education, individuals will be provided with the opportunity to ask questions. In addition, after the education, the researcher's phone will be given and counseling will be provided by phone. The duration and subject of the telephone conversations will be recorded by the researcher. In order to evaluate the training, all patients will be invited to the hospital on the day of the control at the end of 12 and 24 weeks, and evaluations will be made again with data collection tools.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Adherence Report Scale-5	Medication Adherence Report Scale-5: Scores from the 5-point Likert-type scale vary between 5 and 25. An increase in the obtained scores indicates compatibility, and a decrease in scores indicates inconsistency.	24 weeks
Primary	MedTake Test	MedTake Test: It is used to evaluate the use of prescribed oral drugs and to numerically show patients' compliance with drug treatments. With the scale, the daily dose, time and frequency of taking the drug, its effect and reason for taking it, and its relationship with food (hungry-full) are evaluated for each drug. For these 4 parameters, patients score out of 25. In total, the level of knowledge for each drug is scored out of 100. Compliance score for all treatments is calculated with all scores of the patients. Compliance score of the participants in the study is calculated with the total compliance score obtained by each participant.	24 weeks
Primary	Liver Disease Symptom Index 2.0	Liver Disease Symptom Index 2.0: The scale is divided into two parts and includes 24 questions in total. The first part consists of a total of 18 questions, 9 main and 9 sub-questions, questioning the effects of the disease in the last 1 week, and the second part consists of 6 main questions questioning the effects of the disease from the time the patient learned about the disease to the present. The answer to each question in the scale receives a score between a minimum of '1' and a maximum of '5'. '1' is the lowest score; '5' represents the highest score. Higher scores from the scale indicate worse quality of life.	24 weeks
Primary	Composite 12 Item Short Form Health Survey	Composite 12 Item Short Form Health Survey: It has a physical and mental component. Both the Physical Component Scale-12 and the Mental Component Scale-12 scores range from 0 to 100, with a higher score indicating better health.	24 weeks