Effects of a Rheumatoid Arthritis Self-management Program

NCT ID: NCT03470740

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2018-07-31

Brief 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.

Detailed 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.

Conditions

Arthritis, Rheumatoid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

intervention group

An individualized 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.

Group Type: OTHER

rheumatoid arthritis self-management program

Intervention Type: BEHAVIORAL

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.

control group

The control group received general information on rheumatoid arthritis care and follow-up.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Su-Hui Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor, School of Nursing, Chang Gung University of Science and Technology

Locations

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Countries

Taiwan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ChangGungMHRA

Identifier Type: -

Identifier Source: org_study_id