Effects of a Rheumatoid Arthritis Self-management program-a Randomized Controlled Trial
Phase: NA
Conditions: Arthritis, Rheumatoid
Sponsor: Chang Gung Memorial Hospital

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Official Title: Effects of a Rheumatoid Arthritis Self-management program-a Randomized 
Controlled Trial  
NCT number: NCT03470740 
Date of the document: 20160801  
 
Background 
Rheumatoid arthritis (RA) is a persistent systemic disease (Flurey et al., 2014; WHO, 2003). 
The prevalence of RA is 0.3% - 1% worldwide (WHO, 2003), and 0.6% in Taiwan (Chou, 2003). 
Within a decade of its onset, RA leads to work disability defined as a total cessation of employment 
in between 51% and 59% of patients (WHO, 2003). In Taiwan, the Ministry of Health and Welfare 
(2014) emphasized that people suffer from knee joint degeneration is up to 15% prevalence, and the 
most common cause including RA. WHO (2003) commented that although the mortality rate of RA 
is low, a decreased life expectancy is associated with some musculoskeletal disorders, inflammation 
of the multi-system, and ischemic heart disease. The impact of RA including reduction of patients’ 
daily activities, effects on the different dimensions of the quality of life, reduce work capacity (Lee 
et al., 2010; WHO, 2003), and significant increase health care costs (Furner et al., 2011). 
Epidemiological data indicate that individuals with RA are most often diagnosed in their 40s (Lin et 
al., 2004). With the disease continuing into old age, we can anticipate that the number of older 
patients with RA is increasing on a worldwide basis. In Taiwan, the life expectancy is increase and 
the average life span achieves 79.84-year (Ministry of the Interior, 2015), and indicate that 
individuals with RA need to live with the disease for more than 40 years. 
Patients’ involvement in the management of their care is referred to as self-management, 
which has been defined by Barlow and colleagues (2002, p.178) as “the individual’s ability to 
manage the symptoms, treatment, physical and psychosocial consequences and life style changes 
inherent in living with a chronic condition”. Barlow further states that for SM to be effective, it 
needs to encompass the ability to monitor one’s condition and to affect the behavioral and 
emotional responses necessary to maintain a satisfactory quality of life. This definition implies that 
SM is more than simple adherence to treatment guidelines because it incorporates the psychological 
and social management of living with a chronic illness. SM involves, on the patient’s part, acquiring 
the knowledge, practicing the skills and developing the confidence to deal with disease-related 
problems, and making and maintaining behavioral changes to maximize well-being (Dures & 
Hewlett, 2012). Chronic diseases such as RA and related conditions have no ‘cure’, the goal of 
intervention is to minimize disease impact and optimize physical, emotional, and social health 
(Keysor et al., 2001). Day-to-day SM is extremely important in achieving optimal health outcomes, 
and people with arthritis use a variety of strategies to relieve symptoms or manage disease 
consequences (Keysor et al., 2001). Hence, SM in arthritis tends to adopt a more holistic approach 
including management of psychosocial consequences and life style changes (Barlow et al., 2002). 
 

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Methods  
Research Design 
An experimental design was used to examine the effectiveness of a SM intervention for RA 
patients.  
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: (1) diagnosed with RA, (2) age of 20 years or over, (3) disease considered 
by the treating rheumatologist to have been stable for at least 3 months, and (4) able to understand 
and comply with the study treatment. Patients were excluded if they are suffering from other 
terminal illnesses, severe dementia or another debilitating psychiatric disorder, living in a long-term 
care facility, and participation in another research protocol. All patients were under the medical care 
of their rheumatologist during the study. 
Sampling Procedure 
Patients were approached for recruitment when they visit in the medical center rheumatology 
departments. If the patients meet the inclusion criteria and agree to participate in the study then 
randomly assigned to the experimental and control groups were proceeded using a computerized 
allocation procedure in SPSS 17.0 for Windows by an independent researcher. A numbered 
envelope was given. The big and opaque envelopes were numbered from 1 to 260 and contained the 
baseline data collection questionnaires and another sealed of small opaque envelope. The small 
opaque envelope contained a randomly determined using the computer-generated sequence of 
random numbers: number zero is for the control group and number one is for the experimental 
group. The researcher opened the big envelop and collect the baseline data, and then open the small 
sealed envelope to randomly assign participants to two groups. If the patient is random assigned to 
the control group, the usual care of the RA was received. Another experimental group received the 
program. For this sampling procedure, neither the researcher nor the participant is aware of 
treatment group assignment until after the baseline questionnaire has been collected. The 
CONSORT (Consolidated Standards of Reporting Trials) flow diagram (Moher et al., 2001) will be 
followed to manage the random allocation. 
Intervention Program 
The intervention program was based on self-efficacy theory (Bandura, 1977, 1986, 2004), and 
the four resources of self-efficacy such as mastery experience, social modeling, social persuasion, 
and physical and emotional states will be incorporate to emphasize patients’ knowledge, skill, and 
responsibility in managing their RA situations. Various sources of information affect efficacy 
judgments and influence how people weigh and integrate them into actions.  
Instruments and Outcome Measurements 

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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, 3, and 6 months including RA disease activity (DAS-28), arthritis self-efficacy 
(ASE), physical functioning (MHAQ), quality of life (SF-36), self-management behaviors, and and 
health care utilization. 
Procedure and Data Collection 
The researcher contacted the RA patients if they meet the inclusion criteria, and a face-to-face 
interview started. The researcher explained the purpose and procedure of the project, as well as the 
participants’ rights and the benefits of participating. Next, participants agreeing to participate signed 
consent forms. Regarding collection the data, the baseline data was collected including background 
information, disease activity, arthritis self-efficacy, quality of life, physical functioning, 
self-management behaviors, and health care utilization. It followed questionnaire guide to collect 
data, and the person who collected the data and the researcher who visit the patient for the 
intervention was never the same. After completion of baseline data, patients were randomly 
allocated to the intervention or control group by an independent researcher. Control patients 
received usual care, and the intervention group received the 6-week RA self-management program. 
All participants were followed up for 6 months, and the data were all collected at the RA OPD 
when patients were back to the clinic.   
Data Analysis 
Data were double entered for verification and the level of significance was set at alpha of .05 
using SPSS Version 17.0. Descriptive statistical analyses were used to establish baseline 
characteristics of RA patients using means, ranges, standard deviations, frequencies, and 
percentages. Background characteristics and outcomes at baseline were compared between two 
groups by means of chi-square tests and t-tests for independent samples. To evaluate the effect of 
the intervention over the total follow-up period, we used the multiple linear regression method used 
in the GEE (Liang & Zeger, 1986) to take into account of internal dependencies within subjects 
(due to the repeated measurements) and to adjust for the effects of certain factors. Effects evaluated 
included the main effects of time and group and two-way interaction effect(s) of time by group. A 
significant interaction effect of time by group would indicate a significant change from baseline to a 
specific later time point between the two groups. Significant interaction effect(s) in GEE results 
would provide evidence of intervention effects.  
Ethical Considerations 
The study was reviewed and approved by the Institutional Review Boards of the hospitals of 
the PI prior to data collection. The participants were informed both orally and in writing about the 
purpose of the study, assured that participation was voluntary, and the benefits of participating. To 
ensure the security of the intervention, the researcher discussed with the physician about the 
potential participants’ condition and their self-management. They signed the informed consent, was 
guaranteed confidentiality, and was assured an anonymous presentation of the findings.  

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