Back to resultsThe Effect of Education on Drug Compliance and Quality of Life in Hepatitis B Patients
Primary Purpose
Hepatitis B, Chronic, Adherence, Medication, Quality of Life
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
effectiveness of education
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis B, Chronic focused on measuring chronic hepatitis B, adherence, medication, quality of life
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,
- Patients who do not meet the sample inclusion criteria.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Composite 12 İtem Short Form Health Survey
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05286216
First Posted
February 23, 2022
Last Updated
March 17, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
1. Study Identification
Unique Protocol Identification Number
NCT05286216
Brief Title
The Effect of Education on Drug Compliance and Quality of Life in Hepatitis B Patients
Official Title
The Effect of Education on Oral Antiviral Use on Medication Compliance and Quality of Life in Patients With Hepatitis-B Diagnosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 15, 2022 (Anticipated)
Primary Completion Date
April 15, 2022 (Anticipated)
Study Completion Date
December 25, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic, Adherence, Medication, Quality of Life
Keywords
chronic hepatitis B, adherence, medication, quality of life
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
effectiveness of education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medication Adherence Report Scale-5
Description
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.
Time Frame
24 weeks
Title
MedTake Test
Description
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.
Time Frame
24 weeks
Title
Liver Disease Symptom Index 2.0
Description
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.
Time Frame
24 weeks
Title
Composite 12 İtem Short Form Health Survey
Description
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.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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,
Patients who do not meet the sample inclusion criteria.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Education on Drug Compliance and Quality of Life in Hepatitis B Patients
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