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

NCT ID: NCT05286216

Last Updated: 2022-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-15
• Study Completion Date: 2022-12-25

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.

Conditions

Hepatitis B, Chronic; Adherence, Medication; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Experimental group

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.

Group Type: EXPERIMENTAL

effectiveness of education

Intervention Type: BEHAVIORAL

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.

Control group

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 in the first evaluation, 12 weeks and 24 weeks later, the scales were re-applied and the education was improved. effectiveness will be evaluated.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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,

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Sengul KORKMAZ BINAY

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Sengul Korkmaz Binay Tez

Identifier Type: -

Identifier Source: org_study_id