Effects of a Rheumatoid Arthritis Self-management Program

NCT03470740 | Completed Results

• 1 other identifier: ChangGungMHRA
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis, Rheumatoid

Keywords

rheumatoid arthritis, self-management, self-efficacy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Arthritis Self-efficacy- Pain

  6 months

• Arthritis Self-efficacy- Other

  6 months

• SF-36 Quality of life_Physical Component Scores

  6 months

• Physical Functioning

  6 months

• Self-management Behaviors

  6 months

Study Arms (2)

intervention group

OTHER

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.

Behavioral: rheumatoid arthritis self-management program

control group

NO INTERVENTION

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

Interventions

rheumatoid arthritis self-management program 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.

intervention group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Suffering from other terminal illnesses, severe dementia or another debilitating psychiatric disorder
• Living in a long-term care facility
• Participation in another research protocol

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 33303, Taiwan

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Su-Hui Chen
• Organization: Chang Gung University of Science and Technology

sophee@mail.cgust.edu.tw

886-3-2118999

Study Officials

• Su-Hui Chen, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher who collected the data and the researcher who applied the intervention program was never the same.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomly assigned to experimental group who received a rheumatoid arthritis self-management intervention based on self-efficacy theory for 6 weeks, and a control group receiving standard rheumatology care only.

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 20, 2018
• Study Start: September 1, 2016
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: August 22, 2025
• Results First Posted: August 28, 2019

Record last verified: 2018-03

Locations

TW (1)