Journal of Clinical Trials
Open Access

A project of evaluation the effects of a rheumatoid arthritis self-management program: A randomized controlled trial

International Conference on Clinical Trials

July 27-29, 2015 Orlando-FL, USA

Su-Hui Chen1 and Jung-Hua Shao2

Posters-Accepted Abstracts: J Clin Trials

Abstract :

Background: Rheumatoid arthritis (RA) is a persistent systemic disease, and patients will live with the disease longer because the
increase of the life expectancy. WHO commented that a crucial goal of treatment for RA is prevention of loss of daily function
by patient’s self-management (SM) skills. In Taiwan, the treatment of RA is often focused on the biomedical aspects and patient
education is mainly through brief and in frequent interactions with the health care system. A comprehensive self-management
strategy for patients’ day-to-day self-management is limited.
Aims: The primary objective is to determine the feasibility and acceptability of the SM for patients with RA especially focus on
joint activity and joint protection. The secondary objective is to determine the effectiveness and appropriateness of the program
with a focus on physical function and patient reported measurements over a 12 months follow-up.
Methods: To achieve the research goal, the three years of this proposal will be divided into two phases. The phase-1 will conduct to
develop the program and psychometric test of the instruments and to pilot test the feasibility of the research protocol. Regarding
the phase-2 study, the main purpose is to implement the SM intervention for people with RA using experimental design. A medical
center in northern Taiwan will be selected as the research setting and the permission to recruit participants will be obtained
from the director of the medical center before data collection. Patients who visited the rheumatology departments of the medical
center will be eligible for the study. The inclusion criteria show as follows: (1) diagnosed with RA, (2) age of 20 years or over,
(3) disease considered by the treating rheumatologist to have been stable for atleast 3 months, (4) no surgery planned in the 12
months from study baseline and (5) able to understand and comply with the study treatment. Patients will be excluded if they are
suffering from other terminal illnesses, severed ementia or another debilitating psychiatric disorder, living in a long-term care
facility and participation in another research protocol. After completion of baseline measurements, patients will be randomly
allocated to the intervention or control group using a computerized allocation procedure. The sample size estimation will based
on the Generalized Estimating Equations (GEE) analysis. After analysis, the minimum participants for each group will be 130
persons yield a 15% drop out rate. Control patients received usual care, consisting of regular checkups with the rheumatologists.
Patients allocated to the intervention group received the 8-week SM in addition to usual care. The program focuses on joint activity
and joint protection SM based on Bandura’s self-efficacy theory. The independent variable of the SM intervention is based on four
information sources of efficacy expectations include mastery experience, social modeling, social persuasion and physical and
emotional states. The strategies using to enhance SM behavior involve education, goal setting and attainment, self-monitoring,
home visit and telephones delivered. All participants will follow up for 12 months and the data will be collected in the baseline
and 2, 3, 6 and 12 months. The descriptive and inferential statistics with the GEE analysis will be used to evaluate the intervention
outcomes such as the Disease Activity Score-28 (DAS-28), arthritis self-efficacy scale, health assessment questionnaire, quality of
life measure (SF-36), self-management behaviors and health care utilization. And, in the end of the study, the satisfaction with the
self-management will also be evaluated for the experimental group. The results of this project would benefit for RA patients and
health care professionals to generate an effective SM model.

Biography :

Su-Hui Chen after completing her basic nursing education, she worked for ten years as a staff nurse in a medical center and held joint positions as an Associate
Professor at the Chang Gung University of Science and Technology since 2007 in Taiwan. She earned Doctoral degree in nursing at The University of Texas at
Austin, USA, in 2007. Her specialty is interesting in gerontology nursing