Effects of a Rheumatoid Arthritis Self-management Program
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|ClinicalTrials.gov Identifier: NCT03470740|
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : March 23, 2018
Rheumatoid arthritis (RA) is a persistent systemic disease. WHO (World Health Organization) commented that a crucial goal of heath care for RA is prevention of loss of daily function by patients' self-management (SM) skills; however, a comprehensive rheumatoid arthritis self-management (RASm) for RA patients' day-to-day self-managing is limited in Taiwan.
Aims: The aims of the study are: (1) to implement the RASm program, (2) to determine the effectiveness of the program with 6 months follow-up, and (3) to understand participants' experiences when receiving the RASm program for the experimental group.
|Condition or disease||Intervention/treatment||Phase|
|Arthritis, Rheumatoid||Behavioral: rheumatoid arthritis self-management program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Effects of a Rheumatoid Arthritis Self-management program-a Randomized Controlled Trial|
|Actual Study Start Date :||September 1, 2016|
|Estimated Primary Completion Date :||July 31, 2018|
|Estimated Study Completion Date :||July 31, 2018|
An individualized home-based rheumatoid arthritis self-management program for managing RA patients' physical behavioral problems was applied for the intervention group. The program was based on the self-efficacy theory and the four resources were incorporated to emphasize patients' knowledge, skill, and responsibility in managing their RA situations.
Behavioral: rheumatoid arthritis self-management program
The intervention group received the rheumatoid arthritis self-management program which was based on Bandura's theory of self-efficacy and proposes that self-efficacy is influenced by four information sources: mastery of experience, social modeling, social persuasion and one's physical and emotional states. To enhance participants' self-management skill, the following strategies were employed: peer story-telling, assessment, family involvement, goal setting, self-monitoring, self-evaluation, and phone calls consultation.
No Intervention: control group
The control group received general information on rheumatoid arthritis care and follow-up.
- Disease activity [ Time Frame: 6 months ]Disease activity was measured using the DAS-28 (Disease Activity Score-28) which evaluated 28 tender and swollen joint counts of rheumatoid arthritis patients. This scale was used to calculate the 28 tender and swollen joint counts. Scores can range from 0 to 9.4. The lower score represent a better RA outcome.
- Arthritis Self-efficacy- pain [ Time Frame: 6 months ]We used the arthritis self-efficacy-pain (ASE-pain) to measure RA patients' pain self-efficacy. The ASE-pain used visual analogue scales (0-10), in which 0 means 'very uncertain' and 10 means 'very certain'; a higher score refers to higher self-efficacy.
- Arthritis Self-efficacy- other [ Time Frame: 6 months ]We used the arthritis self-efficacy-other (ASE-OS) to measure RA patients' other symptoms self-efficacy. The ASE-OS used visual analogue scales (0-10), in which 0 means 'very uncertain' and 10 means 'very certain'; a higher score refers to higher self-efficacy.
- Quality of life [ Time Frame: 6 months ]The Short-form 36 includes one multi-item scale that assesses 8 dimensions of health: physical functioning (PF), social functioning (SF), role limitations because of physical health problems (RP), bodily pain (BP), general mental health (psychological distress and well-being; MH), limitations in usual role activities because of emotional problems (RE), vitality (energy and fatigue; VT), and general health perceptions (GH), was used to assess the quality of life in this study.
- Physical functioning [ Time Frame: 6 months ]The Modified Health Assessment Questionnaire was used to measure the physical functioning for this study.
- Self-management behaviors [ Time Frame: 6 months ]To assess self-management behaviors the researchers developed a joint activity and protection self-management behaviors scale. The scale consists of eight items and ranges from zero for 'never' to four for 'always'. Higher scores indicate a higher level of use of each of the self-management behavior.
- Health care utilization [ Time Frame: 6 months ]Four items of the Stanford Health Care Utilization scale was measured from the self-reported number of contacts with general physicians including clinical and emergency visits as well as hospitalizations. We calculated the number of patients' medical visits, and the score can be from zero to the number of actual medical visits.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470740
|Contact: Su-Hui Chen, PhD||+886-3-2118999 ext firstname.lastname@example.org|
|Chang Gung Memorial Hospital||Recruiting|
|Taoyuan, Taiwan, 33303|
|Contact: Su-Hui Chen, PhD +886-3-2118999 ext 3216 email@example.com|
|Principal Investigator:||Su-Hui Chen, PhD||Professor, School of Nursing, Chang Gung University of Science and Technology|