Effects of a Rheumatoid Arthritis Self-management Program

Arthritis, Rheumatoid Clinical Trial

Official title:

Effects of a Rheumatoid Arthritis Self-management program-a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03470740
• Other study ID #: ChangGungMHRA
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: July 31, 2018

Study information

• Verified date: March 2018
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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 program for RA patients' day-to-day self-managing is limited in Taiwan. The aims of the study are: (1) to implement the rheumatoid arthritis self-management program, and (2) to determine the effectiveness of the program with 6 months follow-up. The project will design to implement and evaluate the rheumatoid arthritis self-management program for RA patients using two groups experimental design. A medical center in northern Taiwan will be selected and patients who visited the RA departments will be eligible for the study if they are: (1) diagnosed with RA, (2) age of 20 years or over, (3) disease considered have been stable for at least 3 months, and (4) able to understand and comply with the study treatment. After completion of baseline data, patients will be randomly allocated to the intervention or control group using a computerized allocation procedure and follow the CONSORT flow diagram. Control patients received usual care, and the intervention group will receive the 6-week rheumatoid arthritis self-management program which based on self-efficacy theory. The independent variable of the program will be the four information include mastery experience, social modeling, social persuasion and physical and emotional states, and the strategies involve education, goal setting and attainment, self-monitoring, and phone calls. All participants will follow up for 6 months, and the data will be collected at the baseline, and 2, 3, and 6 months. The statistics with the GEE (generalized estimating equation) analysis will be used to evaluate the outcomes such as the disease activity (DAS-28), arthritis self-efficacy (ASE), physical functioning (MHAQ), quality of life (SF-36), and self-management behaviors. Through enhance the capacity of self-management program for the RA cases to reduce the health care utilization and patients' and caregivers' burden.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with RA

• Age of 20 years or over

• Disease considered have been stable for at least 3 months

• Able to understand and comply with the study treatment

Exclusion Criteria:

• Suffering from other terminal illnesses, severe dementia or another debilitating psychiatric disorder

• Living in a long-term care facility

• Participation in another research protocol

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Activity	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.	6 months
Secondary	Arthritis Self-efficacy- Pain	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. This scale have 5 items, therefore, the score range will be 0-50.	6 months
Secondary	Arthritis Self-efficacy- Other	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. This scale have 6 items, therefore, the score range will be 0-60.	6 months
Secondary	SF-36 Quality of life_Physical Component Scores	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. The original scale using the Likert scoring method, the score is from 1-3 or 1-5. Before the scores are added, we follow the SF-36 manual, adjust each item scored from 0 to 100, with 0 indicating extreme problems and 100 indicating no problems. The physical component scores (PCS) included GH, PF, RP, and BP, then the scores of each sub-question under the Physical Component Scores are summed together, and the range after adjustment from 0 (extreme problems) to 400 (no problems) for the Physical Component Scores.	6 months
Secondary	Physical Functioning	The 8-item Modified Health Assessment Questionnaire was used to measure the physical functioning for this study. The MHAQ measures eight activities such as dressing and grooming, arising, eating, walking, hygiene, reach grip, and common daily activities. Items are rated from 1 = without difficulty, to 4 = unable to do; a lower score indicates a greater ability to conduct daily activities. The range of the score will be 8-32.	6 months
Secondary	Self-management Behaviors	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. The range of the score will be 0-32.	6 months
Secondary	SF-36 Quality of Life_Mental Component Scores (MCS)	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. The original scale using the Likert scoring method, the score is from 1-3 or 1-5. Before the scores are added, we follow the SF-36 manual, adjust each item scored from 0 to 100, with 0 indicating extreme problems and 100 indicating no problems. The mental component scores (MCS) included RE, SF, VT, and MH, then the scores of each sub-question under the Mental Component Scores are summed together, and the range after adjustment from 0 (extreme problems) to 400 (no problems) for the Mental Component Scores.	6 Months