Effectiveness of Mobile Application Self-management Program (App) for Joint Protection and Physical Activity in Patients With Rheumatoid Arthritis
Phase: NA
Conditions: Arthritis, Rheumatoid
Sponsor: Chang Gung Memorial Hospital

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Official Title: Effects of a Mobile Application RA Joint Protection and Activity Self-management 
Program  
NCT number: NCT05570175 
Date of the document: 20180801  
 
Background 
Physical activity and joint care are the import parts for the rheumatoid arthritis (RA) patients 
because physical disability is the most common outcome of RA (Chiou et al., 2009; Flurey et al., 
2014). The synovial joints inflammation causes pain and stiffness, and turning simple daily 
activities into challenges (Chiou et al., 2009; Swann, 2011; HO, 2014). The symptoms of RA can 
vary considerably from day-to-day and alter throughout each day which is especially prominent in 
the morning or after prolonged sitting (Swann, 2011). When the disease is not in an active stage, the 
swelling reduces but the joint capsule remains stretched and unable to maintain its correct position, 
and can affect other parts of the body (Swann, 2011). Unfortunately, RA patients tend to lack of 
physically activity because they believed it is unsafe to exercise their joints, or had concerns that 
increased activity would exacerbate their pain (Breedland et al., 2011; Chang et al., 2014).  
Diagnosis of RA most often occurs at 40 years of age and older (Lin et al. 2004), as life span is 
increasing in Taiwan (Ministry of the Interior, Department of Statistics, 2016), RA patients living 
with the disease for more than 40 years. These conditions cannot be cured, but can be managed 
through education, and self-management (Davies, 2010). The evidences from literature presented 
that there are some limitations in traditional self-management interventions (Azevedo et al., 2015; 
Lorig et al., 2010; Shigaki, et al., 2013; Stinson et al., 2014). The most important issue is it is 
difficulty in involving all patients (Azevedo et al., 2015). Many patients find it difficult to 
participate in office-based programs because they are out of town or due to pain or functional 
limitations (Shigaki, et al., 2013). One solution to mitigate some of these problems is exploiting the 
benefits of modern technologies such as cellular phones (Allam et al., 2015; Azevedo et al., 2015). 

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The health care domain, like many other fields, benefits from this technological advancement; 
people tend to seek online health information, virtual communities, and Web-based apps, and many 
other forms of online health services have started to emerge to satisfy people’s needs (Allam et al., 
2015).  
Methods  
Research Design 
An experimental design was used to examine the effects of a mobile application RA joint 
protection and activity self-management program  
Sample and Setting 
A medical center in northern Taiwan was selected as the research setting to ensure sufficient 
numbers of RA patients are able to be recruited for this study, and the teaching hospital is 
constantly striving to improve their services, and is readily accessible to the researcher. Patients 
who visited the rheumatology departments of the medical center was eligible for the study and the 
inclusion criteria include: diagnosis of RA, age of 20 years or over, disease considered by the 
treating rheumatologist to have been stable for at least 12 weeks, able to communicate with 
researcher, and use a smartphone. Patients were excluded if they are suffering from other terminal 
illnesses, severe dementia or another debilitating psychiatric disorder, or living in a long-term care 
facility. All patients were under the medical care of their rheumatologist during the study. 
Sampling Procedure 
Patients with rheumatoid arthritis were approached for recruitment by research assistants when 
they were admitted to the clinic at the rheumatology departments of the medical centers. If the 
patients met the inclusion criteria, agreed to participate in the study, and signed informed consent 
was obtained, baseline data were collected. Following collection of baseline data, an independent 
researcher randomly assigned participants to the intervention or control group using a computerized 
allocation procedure in SPSS 22.0 for Windows; sequential numbers were generated and placed in 
sealed opaque envelopes, which designated the two groups. Thus, neither the participants nor the 

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researcher was aware of the group assignment until after the baseline questionnaire had been 
completed. The CONSORT (Consolidated Standards of Reporting Trials) flow diagram (Moher et 
al., 2001) was followed to manage the random allocation. 
Intervention Program 
The smartphone app was designed to facilitate a self-management program for patients with 
rheumatoid arthritis (Shao et al., 2021), which focused on joint activity and protection because these 
are recognized as vital aspects of managing symptoms of arthritis (Chaleshgar-Kordasiabi et al., 
2018). The design of the program was guided by the literature regarding self-management for 
patients with rheumatoid arthritis (Domin et al., 2022) as well as the opinions and expectations of 
patients and healthcare experts about what should be included in a web-based rheumatoid arthritis 
self-management program. Feedback from patients and healthcare experts was integrated into our 
smartphone app to fit the needs of patients with rheumatoid arthritis.  
Instruments and Outcome Measurements 
Many of the standard measuring instruments selected have been used in previous studies of 
people with arthritis, and have established reliability and validity. Outcome data were collected at 
the baseline, and 2, and 3 months including RA disease activity (DAS-28), arthritis self-efficacy 
(ASE), physical functioning (MHAQ), and self-management behaviors. 
Procedure and Data Collection 
We evaluated whether the app facilitated changes in self-management strategies and improved 
outcomes by examining differences in data collected at baseline (T0) with data collected at 8-weeks 
(T1) and 12-weeks (T2) after commencement of the program for the intervention group compared 
with the control group. Self-report questionnaires were used to measure variables considered 
important for assessing the effectiveness of a self-management intervention: disease activity 
(symptoms of rheumatoid arthritis), arthritis self-efficacy, physical functioning, and self-
management behaviors (Barlow et al., 2002). These self-report questionnaires, described below, 
have been shown to be reliable and valid instruments for patients with arthritis. 

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Data Analysis 
Data were analyzed using the statistical software package SPSS 22 (IBM SPSS, Armonk, NY: 
IBM Corp), and .05 significant level was set. We tested the intervention effect by using GEE 
models. A robust standard error was calculated for consistent parameter estimates and an 
exchangeable working correlation matrix was used to account for the outcome dependency within 
individual participants (Liang & Zeger, 1986). Each GEE model included main effects of group 
(intervention vs. control), time (month vs. baseline) and two-way interaction effects (group x time). 
The group difference in the change from baseline to 2-months, or 3-months between two groups 
was verified when the two-way interaction effect(s) (group x time) was statistically significant. 
Ethical Considerations 
This study was reviewed and approved by the Institutional Review Boards of the hospitals of 
the primary investigator prior to data collection (No. 201702125B0, Date of Approval: 2018/01/08). 
The program occurred on a secure online platform and participant confidentiality was protected 
throughout all phases of the study in accordance with the University ethics guidelines. Only the 
research team had access to study data and only de-identified data were transmitted to 
coinvestigators. All patients were assured their anonymity and confidentiality would be preserved, 
and they could withdraw from the study at any time and for any reason. Signed informed consent 
was obtained from all participants prior to beginning the study. 
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