Aim and study design
The aim of this study was to evaluate the effects of a 12-week patient education program delivered by WeChat on depression, quality of life and clinical outcomes in Chinese patients with AS. This study was an assessor-blind, parallel-group, randomized controlled trial conducted between March to December 2017.
Ethical considerations
This study was conducted in accordance with the Helsinki declaration. Ethical approval was obtained from West China Hospital Medical Ethics Committee in 2016(ID: 20160364). All participants were informed the content and procedure of this study and provided informed consent.
Participants
Eligible patients were recruited from the Department of Rheumatology and Immunology at West China Hospital Sichuan University, Chengdu, China. The inclusion criteria were as follows: fulfilling the modified New York classification criteria for AS[24], aged≥14 years, able to understand/read Chinese, able to use the WeChat, and willing to participate in this study. We excluded patients who had severe psychological and cognitive impairment, and were participating in other studies. Patients with other rheumatic diseases were also excluded.
Patients were enrolled and randomly allocated into the intervention group or the control group using a randomization code generated by the Excel software. The assessors who collected data were blind to the allocation of the participants.
Intervention group
Participants in the intervention group received the 12-week educational intervention delivered by WeChat and standard care. The educational intervention was mainly carried out by experienced research nurses who were well-trained the study protocol. The content of the educational intervention was developed on literature review, expert consultation, and a pilot study. The core content was as follows: basic knowledge, exercise, medication, daily life management, psychological support, self-assessment.
During the 12-week intervention, participants in the intervention group received four individual educational sessions and online educational information on WeChat platform. The four individual educational sessions were conducted through WeChat voice/video calls based on participants’ preference, and each session lasted 20-30 min depending on their’ willingness to communicate. At the first educational session, the research nurses assessed participants’ needs, problems and barriers of managing their life. Then, participants were taught the knowledge and skills of managing their condition, including exercise, medication taking, daily life instruction, psychological management strategies. The participants were also taught how to use validated instruments to assess their disease condition. During subsequent sessions the research nurses taught participants strategies to manage their disease based on participants’ problems and health behaviors over the previous 2 or 4 weeks. In addition, the research nurses also sent online educational information including articles and videos to participants once a week. During the whole intervention phase, we encouraged participants to ask questions and share their experience at any time.
Control group
The control group received standard care at hospital. The standard care consisted of basic health advice and brief guidance on medication and exercise. Participants in the control group could ask the researchers questions about disease via WeChat or mobile phone, but did not access to the educational program.
Measures and data collection
All participants completed baseline assessments at the Department of Rheumatology and Immunology. Outcome measures, including quality of life, depression, overall well-being, physical function, morning stiffness, pain, was collected at the baseline and after the 12-week educational intervention. Two well-trained research assistants who were blind to group allocation collected study data at baseline and after the 12-week educational intervention. If participants had difficulties in completing the questionnaires, the research assistants would help them read each item and record their responses.
Participants characteristics
The baseline demographic data included age, gender, educational level, marital status, household income, medical insurance, smoking status. Disease-specific data included disease duration (e.g duration since diagnosis, symptom duration), current medication.
Quality of life
Health related QoL was measured using the Medical Outcomes Study Short Form 36-item Health Survey (SF-36)[25, 26]. The SF-36 consists of 36 items and measures eight aspects of health status during the past 4 weeks. The eight domains of the SF-36 includes: physical functioning(PF), role physical(RP), bodily pain(BP), general health(GH), vitality(VT), social functioning(SF), role emotional(RE) and mental health(MH)[4, 25]. Each domain is scored ranging from 0 to 100, higher scores indicating better QoL[4]. This scale has been translated into different language versions and validated in patients with AS[4, 27]. In this study, the Cronbachs’ a of total score was 0.87, and the Cronbachs’ a of each domain ranged from 0.777 to 0.915.
Depression
Depression was evaluated using the Chinese version of Beck Depression Inventory-Ⅱ BDI-Ⅱ)[28]. The BDI-Ⅱ is a validated self-reported questionnaire developed by Beck et al[29]. It comprises 21 items and evaluate the severity of depressive symptoms during the past two weeks [30]. Each item score ranges from 0 to 3, and total score ranges from from 0 to 63. Higher scores indicate severer depressive symptoms[28, 31]. In current study, the cronbach’s a was 0.837.
Disease specific measures
The Bath Ankylosing Spondylitis Patient Global Score (BAS-G) was used to assess the effect of AS on overall patients’ well-being over the last week and during the last six months[32]. The test-retest reliability of BAS-G was excellent, and construct validity and predictive validity was good[32]. The BAS-G ranges from 0-10 and higher scores indicate worse patients’ global assessment. Physical function was measured by the Bath Ankylosing Spondylitis Functional Index(BASFI)[33]. The BASFI scores ranges from 0-10 and higher scores indicate worse physical function[33]. Patients’ overall pain, back pain, nocturnal pain, and morning stiffness were collected using a visual analogue scale, and final scores range from 0(none) to 10(severe).
Statistical analysis
All data were analyzed using the Statistical Package for Social Sciences 22.0(SPSS Inc., Chicago, IL, USA). The intention-to-treat analysis(ITT) method was used to analyze data. Participants’ characteristics and outcome scores were summarized using means ± standard deviation(SD) or medians [interquartile ranges] (IQR) for continuous variables, or frequencies (percentages) for categorical variables. Baseline characteristics and outcomes were compared using independent samples t test or Mann-Whitney U-test from continuous variables, and Chi-squared test for categorical variables between the intervention and control group. P values < 0.05 were considered statistically significant.