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Trial registered on ANZCTR


Registration number
ACTRN12618000562279
Ethics application status
Approved
Date submitted
9/02/2018
Date registered
13/04/2018
Date last updated
13/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomized Controlled Trial Using Education Intervention on Hepatitis C Treatment Adherence Among Libyan Patients in Tripoli Medical Center
Scientific title
Randomized Controlled Trial Using Education Intervention on Hepatitis C Treatment Adherence Among Libyan Patients in Tripoli Medical Center
Secondary ID [1] 294012 0
Nil known
Universal Trial Number (UTN)
U1111-1209-2021
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 306744 0
Condition category
Condition code
Public Health 305635 305635 0 0
Health promotion/education
Infection 305835 305835 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 103 eligible participant patients allocated randomly to intervention and control groups.
Respondents for both intervention and control group were single-blind to reduce bias. Only the researcher can differentiate which groups are under intervention or control group. The intervention group received information ’s about general information on hepatitis C infection, risk factors, complication, screening, prevention, diagnosis, treatment and side effects of treatment and tips on treatment adherence in the form of the powerpoint presentation and education booklet.
The control group did not receive any information’s related to hepatitis C. Both the intervention and control groups received the usual care by their therapied physician. After the completion of the trial, the control group received the educational material booklet.
The education intervention guided by Social Cognitive Theory. The principal author who is a Ph.D. student in epidemiology and biostatistics, herself prepared the education material and highlighted the study objectives by comprehensive literature review from previous studies. Also, the principal researcher conducted the education session and distributed the education booklet to the intervention group. All the patients in the intervention group received one session and about 3 to 5 patients per session.
The recruitment period for the study was five months. After that, all patients in both groups answered a set of validated and pretested questionnaires at baseline, and intervention group received the educational intervention. Then all patients answered the same a set of questionnaires at 3-months and 6-months post-intervention.
Usual standard care received by both intervention and control group, it is the conventional clinical follow-up evaluation that did by the therapist physician. Usual standard care includes general examination, a blood test of viral load, treatment for any complaints or symptoms, and prescription of RBV and PegIFN treatment

Intervention code [1] 300285 0
Behaviour
Intervention code [2] 300410 0
Treatment: Other
Comparator / control treatment
The control group was in usual care with their therapist physician. The usual care includes general examination, a blood test of viral load, treatment for any complaints or symptoms, and prescription of RBV and PegIFN treatment.
Control group
Active

Outcomes
Primary outcome [1] 304745 0
Hepatitis C treatment adherence is the primary outcome, measured by self- administered adherence questionnaire named (self-reported medication adherence for hepatitis C), which has been validated by (Smith et al., 2007) and also pretested for this study.
Timepoint [1] 304745 0
The primary time point is baseline before introducing the educational intervention. As included in eligibility criteria, the patients recruited for this study should be undergoing HCV treatment for one to two months. So the treatment adherence measured at baseline before the beginning of intervention for a patient who at least one month started his /her treatment.
Other time points are 3-months after intervention commencement and 6-months after intervention commencement.
Secondary outcome [1] 343003 0
Hepatitis C Knowledge measured by reliable and valid self-administered questionnaire named Brief HCV Knowledge scale (Balfour et al., 2009). also pretested for this study
Timepoint [1] 343003 0
At baseline before intervention beginning, at 3-months after intervention commencement, and at 6-months after intervention commencement
Secondary outcome [2] 343496 0
Self-efficacy measured by General Self-Efficacy Scale (GSE),
which is reliable and valid scale (Schwarzer & Jerusalem, 1995), also pretested for this study.
Timepoint [2] 343496 0
At baseline before the beginning of the intervention, at 3-month after intervention commencement, and at 6-month after intervention commencement.
Secondary outcome [3] 343497 0
Virological Response depends on the viral load. The viral load (HCV RNA) measured by testing the blood using Real-time Polymerase chain reaction (PCR) test, which is quicker and more cost-effective method, as it can identify a very low quantity of HCV RNA (10-15 IU/ml) (Vermehren et al., 2008)
Timepoint [3] 343497 0
At baseline before the beginning of the intervention, at 3-month after intervention commencement, and at 6-month after intervention commencement.
Secondary outcome [4] 343498 0
Health-related Quality of Life (HRQL) measure by reliable and valid SF-36v2 health survey (Ware et al., 2008). Also, pretested for this study.
Timepoint [4] 343498 0
At baseline before the beginning of the intervention, at 3-month after intervention commencement, and at 6-month after intervention commencement.

Eligibility
Key inclusion criteria
i) The CHC patients, who are 18 years old and above.
ii) All genotypes of HCV patients can be included.
iii) Patients diagnosed with CHC infection and newly started with PegIFN-a 2a and RBV (naïve patients).
iv) The patients with genotype 2 and 3 must be recruited within the first month of treatment began, and the patients with genotype 1 and 4 must be recruited within first two months of treatment began.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) The patients are not included if known co-infection with HIV or HBV. ii) The patients are not included if had previous treatment with PegIFN and RBV regimen and requiring discontinuation.
iii) The patients are not included if had evidence of advanced liver cirrhosis or esophageal varices. iv) The patients are not included if had a history of severe and uncontrolled psychiatric disorders. v) The patients are not included if had active alcohol or drug abuse.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The 103 eligible participant patients allocated randomly to intervention and control groups. The allocation sequence generated by general practitioner working in the infectious department. The software used for the randomization was from the web page; “Create a blocked randomization list” (Sealed Envelope, 2001). The blocks of size four and six randomly selected; this method ensures equal allocation to the intervention and the control group within each block (1:1). The patients received the randomly generated treatment allocations codes (unique codes, e.g., BW4, IW6, AM6, and DM9) within sealed opaque envelopes. The serial number for each patient (e.g., 1, 2, and 3) was written on the front of sealed envelope depending on patient’s attendance. These numbers to identify them on the questionnaire to maintain confidentiality. The therapist doctors distributed the sealed opaque envelopes to the patients. Later, the researcher opened the envelopes and allocating the patients according to their unique codes to the intervention or control groups based on list codes that generated by a computer. Finally, 51 patient randomly assigned to the intervention group and 52 patients to the control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence generated by general practitioner working in the infectious department. The software used for the randomization was from the web page; “Create a blocked randomization list” (Sealed Envelope, 2001).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The collected data analyzed using IBM SPSS Software version 22. The raw data checked first for normal distribution. The level of significance set at a = 0.05 for the hypothesis testing. Descriptive analysis used to provide information for the total sample and both intervention and control groups, the information about the patients’ treatment adherence, knowledge of hepatitis C, general self-efficacy, HRQL, sociodemographic, social support, and medical history. For between-group comparisons, the independent-samples t-test was used to compare the mean difference of continuous and normally distributed data between intervention and control group. As well, Mann-Whitney-U test used for comparison of continuous and not normally distributed data. The Chi-square test used to compare the frequency difference of categorical data between the intervention and control groups, and for a 2×2 table that contains a cell with an expected count less than 5, Fisher’s exact test used to test the association between the two groups. To assess the changes within both groups, the one-way repeated measures ANOVA was used for continuous and normally distributed variables such as; knowledge of hepatitis C, general self-efficacy, and HRQL to compare the mean difference within the intervention and the control groups at baseline, 3-months, and 6-months. The McNemar test used for virological response to test the frequency within two related samples at 3-months and 6-months. While Cochran’s Q test used for treatment adherence to test the frequency differences within three times at baseline, 3-months, and 6-months.

The Generalized estimating equations (GEE), which is multivariate statistical test was used to test the main effect and interaction between and within the intervention and control groups over times, at baseline, three months, and six months.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9574 0
Libyan Arab Jamahiriya
State/province [1] 9574 0
Tripoli

Funding & Sponsors
Funding source category [1] 298636 0
Self funded/Unfunded
Name [1] 298636 0
Samia Adam
Address [1] 298636 0
Department of community medicine, Faculty of Medicine and Health Science, University Putra Malaysia, Jalan Upm, 43400 Serdang, Selangor, Malaysia
Country [1] 298636 0
Malaysia
Primary sponsor type
Individual
Name
Samia Adam
Address
Department of community medicine, Faculty of Medicine and Health Science, University Putra Malaysia, Jalan Upm, 43400 Serdang, Selangor, Malaysia
Country
Malaysia
Secondary sponsor category [1] 297804 0
Individual
Name [1] 297804 0
Dr Salmiah Md. Said
Address [1] 297804 0
Department of community medicine, Faculty of Medicine and Health Science, University Putra Malaysia, Jalan Upm, 43400 Serdang, Selangor, Malaysia
Country [1] 297804 0
Malaysia
Secondary sponsor category [2] 297806 0
Individual
Name [2] 297806 0
Dr Hayati Binti Kadir Shahar
Address [2] 297806 0
Department of community medicine, Faculty of Medicine and Health Science, University Putra Malaysia, Jalan Upm, 43400 Serdang, Selangor, Malaysia
Country [2] 297806 0
Malaysia
Secondary sponsor category [3] 297807 0
Individual
Name [3] 297807 0
Dr Bahariah Khalid
Address [3] 297807 0
Department of community medicine, Faculty of Medicine and Health Science, University Putra Malaysia, Jalan Upm, 43400 Serdang, Selangor, Malaysia
Country [3] 297807 0
Malaysia
Secondary sponsor category [4] 297808 0
Individual
Name [4] 297808 0
Professor Dr. Mohamed Ali Daw
Address [4] 297808 0
Faculty of Medicine and Health Sciences
Tripoli University, Libya
Country [4] 297808 0
Libyan Arab Jamahiriya
Secondary sponsor category [5] 297809 0
Individual
Name [5] 297809 0
Prof. Maimunah Ismail
Address [5] 297809 0
Faculty of Educational Studies, Universiti Putra Malaysia, 43400 Serdang, Selangor, Malaysia
Country [5] 297809 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299596 0
JKEUPM (Ethic Committee For Research Involving Human Subject)
Ethics committee address [1] 299596 0
Universiti Putra Malaysia,Jalan Upm, 43400 Serdang, Selangor, Malaysia
Ethics committee country [1] 299596 0
Malaysia
Date submitted for ethics approval [1] 299596 0
26/06/2014
Approval date [1] 299596 0
14/11/2014
Ethics approval number [1] 299596 0
UPM/TNCPI/RMC/1.4.18.1 (JKEUPM)/F2

Summary
Brief summary
Hepatitis C infection is a communicable disease caused by infection with hepatitis C virus (HCV). The standard treatment of HCV infection is a combination of Ribavirin (RBV) and Pegylated interferon (PegIFN) for six months or one year. The long duration and the side effects of dual treatment have an enormous impact on patients’ treatment adherence and health-related quality of life (HRQL). This study aims to evaluate the effectiveness of an educational intervention to improve treatment adherence (primary outcome) and to improve secondary outcomes, which include knowledge, general self-efficacy (GSE), virological response, physical components scores (PCS), and mental components scores (MCS) of HRQL. The 103 patients randomly allocated by concealment block randomization, 51 patients to the intervention and 52 patients to control groups. The education material consists of the one-day session of PowerPoint lecture, discussion, and booklet. The data collected at baseline, 3-months, and 6-months post-intervention. Of those 103 patients, 98 patients completed the study (95% response rate), the high response rate yielded low attrition rate of 5%. The study analysis based on intention-to-treat approach. The Generalized Estimating Equation (GEE) was used for analyzing the data using SPSS version 22.

The educational intervention in the current study was effective in sustaining high treatment adherence for RBV and PegIFN treatment within the intervention group. Whereas the control group had a significant decrease in treatment adherence over time. The educational intervention also was efficient in improving HCV knowledge, which was low to moderate among both groups at baseline, but after the intervention, the HCV knowledge was increased over time in the intervention group than in the control group.

Additionally, the self-efficacy was improved within the intervention group than in the control group that attributed to the effectiveness of self-efficacy theory (Bandura) in this study. The HRQL, particularly MCS was much better in the intervention than in the control group. Therefore, the results provide evidence of the effectiveness of the educational intervention to sustain treatment adherence and HRQL and to improve HCV knowledge and self-efficacy. Those findings support the crucial role of education program in improving health outcomes.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80966 0
Dr Samia Adam
Address 80966 0
Department of community medicine, Faculty of Medicine and Health Science, University Putra Malaysia, Jalan Upm, 43400 Serdang, Selangor, Malaysia
Country 80966 0
Malaysia
Phone 80966 0
+60173185889
Fax 80966 0
Email 80966 0
drsamiaadam177@gmail.com
Contact person for public queries
Name 80967 0
Dr Samia Adam
Address 80967 0
Department of community medicine, Faculty of Medicine and Health Science, University Putra Malaysia, Jalan Upm, 43400 Serdang, Selangor, Malaysia
Country 80967 0
Malaysia
Phone 80967 0
+60173185889
Fax 80967 0
Email 80967 0
drsamiaadam177@gmail.com
Contact person for scientific queries
Name 80968 0
Dr Samia Adam
Address 80968 0
Department of community medicine, Faculty of Medicine and Health Science, University Putra Malaysia, Jalan Upm, 43400 Serdang, Selangor, Malaysia
Country 80968 0
Malaysia
Phone 80968 0
+60173185889
Fax 80968 0
Email 80968 0
drsamiaadam177@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary