Hepatitis B, ChronicNCT05286216
The Effect of Education on Drug Compliance and Quality of Life in Hepatitis B Patients
A study testing effectiveness of education in people with Hepatitis B, Chronic and Adherence, Medication, run by Istanbul University - Cerrahpasa.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, Chronic, Adherence, Medication, Quality of Life
- What is being tested?
- effectiveness of education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2022to 25 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 9Show fewer
- 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.
Who cannot join
- •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.
About this study
Official title: The Effect of Education on Oral Antiviral Use on Medication Compliance and Quality of Life in Patients With Hepatitis-B Diagnosis
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
- Being tested
- effectiveness of education
- Keywords
- chronic hepatitis B, adherence, medication, quality of life
- Medical subject headings
- Hepatitis B, Chronic, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
effectiveness of educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Behavioral: effectiveness of education |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
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.
Measured: 24 weeks
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.
Measured: 24 weeks
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start15 Apr 2022 (estimated)
- Primary completion15 Apr 2022 (estimated)
- Study completion25 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sengul KORKMAZ BINAY, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286216
- Sponsor's protocol ID
- Sengul Korkmaz Binay Tez
- Status last verified
- Mar 2022
- First submitted
- 23 Feb 2022
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education on Oral Antiviral Use on Medication Compliance and Quality of Life in Patients With Hepatitis-B Diagnosis
- ClinicalTrials.gov ID
- NCT05286216
- Acronym / sponsor ID
- Sengul Korkmaz Binay Tez
- Conditions
- Hepatitis B, Chronic, Adherence, Medication, Quality of Life
- Keywords
- chronic hepatitis B, adherence, medication, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Apr 2022 (estimated)
- Primary completion
- 15 Apr 2022 (estimated)
- Study completion
- 25 Dec 2022 (estimated)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: effectiveness of educationPatient 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Being diagnosed with CHB for at least 6 months,
Key exclusion criteria (4 listed)
- •Continuing to use alcohol after the first evaluation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| effectiveness of educationThe 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. | Behavioural | Experimental group |
Primary outcome
Medication Adherence Report Scale-5
Time frame: 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.
MedTake Test
Time frame: 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
Time frame: 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.
Composite 12 İtem Short Form Health Survey
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing effectiveness of education in people with Hepatitis B, Chronic and Adherence, Medication, run by Istanbul University - Cerrahpasa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence Report Scale-5 (time frame: 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.