Objective
This study aimed to compare the effectiveness between two different newly developed educational tools; a brochure and a video, in JIA-related knowledge at immediate and four-week post-intervention.
Development of JIA educational tools
The educational brochure and the video were developed by two pediatric rheumatologists. They are comprised of four parts of educational knowledge including 1) general knowledge about JIA and disease etiology, 2) treatment of JIA and adverse effects from medication, 3) selfcare knowledge about physical activities, vaccinations and diet, and 4) knowledge about how to manage when disease relapses. The contents in both brochure and video were similar. The length of a cartoon-designed video was five minutes long. Both materials were reviewed by 10 laypeople to suggest some changes in design and wording.
Revised materials were then applied.
Outcome measures
The JIA knowledge questionnaire was developed and comprised fifteen multiple-choice questions with a choice of five responses. The choice in all questions included not known response to prevent guessing. The purpose of the questionnaire was to assess level of essential knowledge about JIA. The questionnaire included general knowledge (3 items), treatment and drugs complications knowledge (5 items), self-care knowledge (4 items) and disease relapse management (3 items). The correct answers were given one mark and the wrong or non-answered were given zero mark. Knowledge scores ranged from 0 to 15 with lower scores reflecting poorer knowledge about JIA.
In order to evaluate the satisfaction of JIA educational tools, patient satisfaction questionnaire was designed by using a 10-cm visual analog scale. It assessed the overall satisfaction of the educational tools and also addressed five main areas, including usefulness, understanding and clarity of contents, propriety, application and the interest of the educational tools. The scores ranged from 0 to 10 which 0 and 10 indicates not satisfied and the most satisfied, respectively.
Design and participants
This randomized controlled trial study was approved by the Ethics Committee of the Faculty of Medicine Ramathibodi Hospital, Mahidol University. All JIA patients diagnosed by International League of Associations for Rheumatology (ILAR) criteria (14) in the Ramathibodi pediatric rheumatology clinic or caregiver of patients, were enrolled. After need elaboration, informed consent had been obtained. Their caregiver also had provided informed consent if the participant was younger than 18 years. Knowledge and satisfaction questionnaires were answered by patients who graduated at least 8th grade or caregiver of patients who graduated under 8th grade. Patients or caregivers need to be able to read and communicate in the Thai language. Patients living in a nursing facility were excluded. A two-group randomized controlled design by using block size of four was used to compare efficacy of the two intervention groups which were a brochure (n=50) and a video (n=50). All participants answered knowledge questionnaire before (pretest), immediately after the intervention (immediate post-test) and at follow-up four weeks later (four-week post-test). Satisfaction questionnaire was completed immediately after reading the brochure or watching the video. Both groups received the same usual care and treatment based on standard guideline.
Baseline demographics data, including age, sex, disease duration, education level of patients and parents, employment status of parents, geographic region, JIA subtypes, disease activity, and health associated behaviors were collected from medical records and interviewing. Disease activity was assessed by Juvenile Arthritis Disease Activity Score 27 (JADAS-27) (15) and Wallace criteria (16). JADAS-27 score was calculated by summing the scores of four criteria: physician’s global assessment of disease activity (PGA); parents or patients’ global assessment of well-being; number of active joint count; and Erythrocyte sedimentation rate (ESR)(mm/h) using the formula ESR-20/10. The JADAS-27 scores ranged from 0 to 57 where high scores reflected active disease. Wallace criteria was used to define disease status in JIA patients which can be classified into active disease, inactive disease, clinical remission on medication and clinical remission without medication (16). The criteria of Inactive disease patients are 1. No joints with active arthritis – defined by the American College of Rheumatology (ACR), 2. No fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA, 3. No active uveitis, 4. Normal ESR or C-reactive protein (CRP) and 5. PGA indicates no disease activity. Clinical remission with medication defined as patients, who meet the criteria for inactive disease for a minimum of 6 consecutive months while the patient is taking medication. Clinical remission without medication defined as patients, who meet the criteria for inactive disease for a minimum of 12 consecutive months while the patient is off all anti-arthritis and anti-uveitis medication. Finally, patients who are not met inactive criteria were defined as active disease(16).
Statistical analysis
Continuous parameters were shown as mean and standard deviations and nominal parameters were shown as number and percentages. Nominal parameters were analyzed by chi-square test. Paired t-test was conducted to compare the mean knowledge scores of two time points. Non-normal distribution data were analyzed by Wilcoxon sign test. Differences between two independent groups were evaluated by T-test and Mann-Whitney U test. A statistical difference was set at P-value less than 0.05. SPSS-20 programme was conducted to analyze all data.
Trial registration
Trial registration: Thaiclinicaltrials.org 06/03/2020, TCTR20200310004, prospectively registered.