This study is a controlled clinical trial (code number IRCT2015021321056N1) in which the population is patients with hepatitis B who referred to the Imam Khomeini training - health center in Ahvaz and the specialized clinic of Razi hospital in Ahvaz in 2014. Inclusion criteria were a chronic hepatitis B diagnosis confirmed by a physician for at least 6 months, over 18 years old, living in Ahvaz or having the possibility to participate in education sessions, writing and reading literacy, lack of liver cancer and advanced cirrhosis, having the psychological capacity to participate in training sessions, and having a mobile phone (to follow up on their treatment) in all training sessions. Criteria for inclusion were absence in training sessions in two or more sessions.
The sample size was obtained given the results of the pilot study performed on 15 patients (who were part of the main population). Based on the results of the pilot study, which showed a statistically significant difference (P < 0.001) in patients’ knowledge in the intervention group (4.50 ± 2.80) compared to the control group (6.90 ± 2.90), and given the error α = 0.05, β = 0.1, and power = 0.95, 21 people per group were estimated to be included, and considering a 20% loss of samples, the sample size was increased to 50, i.e., 25 patients in each group.
Data collection tools in this study were demographic and clinical profile forms (age, gender, marital status, education, ethnicity, occupation, type of insurance, income, and duration of hepatitis B, family history of hepatitis B, and a history of other diseases) and a researcher-made checklist to evaluate patients’ knowledge. The checklist has 30 three-choice questions evaluating patients’ information in the field of preventive behaviors, such as medical follow-ups (checkups), diet, drugs, and risky behaviors. Responses of “yes,” “no,” and “I do not know” were scored as 1, 0, and 0.5, respectively, and in total, the maximum and minimum scores for the questionnaire were 30 and 15, respectively. This questionnaire was completed by interviewing the patients and by the researcher himself. The checklist prepared by content validity was used for determining scientific validity. Therefore, after studying the books and available resources in this field, a checklist was prepared and available to 10 professors of the nursing and midwifery faculty, Ahvaz. Their agreement was obtained using the components of the proposed framework, and after identifying problems, the necessary corrections were made and the final checklist was developed. Test-retest reliability of the questions was determined; the questionnaire was initially completed by 10 patients (who were not among the research population) and after 10 days, the questionnaire was completed by the same people and the correlation coefficient was determined to be 0.81.
For sampling, after receiving permission from the ethics committee of Ahvaz Jondi Shapur University of Medical Sciences and coordinating with officials of the mentioned centers, the researcher selected patients who met the criteria for inclusion. Then, he discussed the research objective and patients were told that they were free to decline in every stage of the study and the patients and their families were given the right to ask the researcher questions to clarify any ambiguities they may have. They were also assured that the obtained information would remain confidential and they would not be deprived of routine treatment and should not pay any fees for the trial. Written consent was obtained from all the subjects. Then, they were divided randomly (the first subject using the card No.1, which was selected by himself, was assigned to the control group and other subjects were assigned to control and experimental groups consecutively) placed them randomly (first patient was placed in the control group using bolt No. one selected by him and other patients consecutively were placed in two experimental and control groups) into two groups: experimental (n = 25) and control (n = 25). First, the two groups completed the clinical and demographic information forms and awareness questionnaire. Then, patients in the experimental group were taught through care-centered professional participation and in the control group, patients received normal training.
To train based on the care-centered professional partnership model, researchers (master of nursing) served as the main teacher and used the training supervisor (M.S. in nursing who has two years of work experience in an infectious ward and a history of teaching and research as well) as the clinical fellow and 2 patients (those who received a score higher than 25 in the pre-test and had strong communication skills) as the training partners. In this study, the following four steps were conducted to provide professional education based on the care-centered professional partnership model:
1. Formation: In this phase, the clinical partner and the patient representatives serving as the main members formed an introduction session and discussed the objectives, methodology, and training method.
2. Determining the participatory role: In this phase, the role of each member in the training sessions was determined. The researcher developed training programs (providing educational pamphlets and slides), set up training sessions, and led the group. The clinical fellow was obliged to enhance his knowledge and information on the issue and prepare materials to present in training sessions and assist the main teacher in the selection of teaching content. In addition, it was decided that the patient representatives would work together in teaching the group about what they knew.
3. Playing a cooperative role (run): At this stage, according to the learning environment (level of education, location, time, educational purposes), trainers played their role that was defined in step 2 in four training sessions (two sessions per week for 60 minutes and in each session, six patients participated with one person) as follows:
First session: A general background on the types of hepatitis disease, liver function, and the routes of transmission of hepatitis B were presented by the training group through lectures and slide shows.
Second session: At the beginning of the meeting, the subjects were verbally evaluated and the problematic and vague materials were clearly explained again. Then the trainer described a variety of the side effects induced by medicine, coping methods, the rationale for proper nutrition and diet, and how to use herbal medicine. At the end of the session, the subjects were given pamphlets to review at home.
Third session: The material from the previous session was reassessed verbally and in cases of any misunderstanding, the content had to be described again. Then, the prevention methods for hepatitis B in the community (vaccination, public healthcare) as well as those for the transmission of hepatitis B in the family were described (how to use common means, personal communication, and immunization).
Fourth session: As in the previous session, the subjects were first assessed. Then, the trainers described the factors intensifying hepatitis B and other types of hepatitis, diagnostic tests (HbsAg, ALT and HBsAb), and the need for medical follow-up. They also explained addicted and high-risk behaviors by presenting slide shows. Then, in a 15-minute question and answer session (formative evaluation), the trainers reviewed what had been described previously.
4. Empowerment evaluation: At this point, two weeks after the last training session, the patients and their relatives attended the class again and were asked about their follow-up regarding self-care behaviors (such as vaccinations, medication, and diet) and all vague and difficult questions were addressed by the main teacher.
Finally, four weeks after the last stage, the questionnaire was completed again by patients in the control and intervention groups and to comply with ethical issues, pamphlets and instructional slides were prepared for the control group. The collected data were analyzed using SPSS 22. To describe the absolute frequency, relative frequency, mean and standard deviation, and descriptive statistics, and to compare qualitative and quantitative variables of the two groups, independent t-tests and chi-squared tests were used. To compare the pre- and post-intervention scores in each group, paired t-tests were used. For all the tests, P < 0.05 was considered statistically significant.