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

Not Applicable

• Conditions: Quality of Life; Adherence, Medication; Hepatitis B, Chronic
• Interventions: Behavioral: effectiveness of education

• Registration Number: NCT05286216
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-23
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-17
• Last Update Submitted: 2022-03-17
• Study First Posted: 2022-03-18
• Last Update Posted: 2022-03-18
• Study Start: 2022-04-15
• Primary Completion: 2022-04-15
• Study Completion: 2022-12-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	effectiveness of education	Patient diagnosis form with CHB and related scales (Patient Diagnosis Form with Chronic Hepatitis B, Medication Adherence Report Scale-5), Medication Adherence Report Scale (MedTake Test), Chronic Liver Disease Quality of Life Scale 2.0" (Liver Disease Symptom Index 2.0 (LDSI 2.0), Health-Related Quality of Life Scale SF-12" (12 Item Short Form Health Survey) (Short Form 12 - SF 12), Patient Learning Needs Scale will be applied before the intervention. The training will be in two modules and two different sessions. The effectiveness of the training will be evaluated by re-applying the scales 12 weeks and 24 weeks after the training.

Primary Outcome Measures

Name	Time	Method
Medication Adherence Report Scale-5	24 weeks	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.
Composite 12 İtem Short Form Health Survey	24 weeks	Composite 12 İtem 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.
MedTake Test	24 weeks	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.
Liver Disease Symptom Index 2.0	24 weeks	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.