None listed
Conditions
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.
Interventions
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 adhere
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
Sponsors
Samia Adam
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed