Clinical trial NCT03470740: Effects of a Rheumatoid Arthritis Self-management Program
Official title: Effects of a Rheumatoid Arthritis Self-management program-a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis, Rheumatoid
Keywords: rheumatoid arthritis, self-management, self-efficacy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2018-03-20
Enrollment: 224
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Disease Activity
timeFrame: 6 months
Secondary outcomes:
measure: Arthritis Self-efficacy- Pain
timeFrame: 6 months
measure: Arthritis Self-efficacy- Other
timeFrame: 6 months
measure: SF-36 Quality of life_Physical Component Scores
timeFrame: 6 months
measure: Physical Functioning
timeFrame: 6 months
measure: Self-management Behaviors
timeFrame: 6 months
measure: SF-36 Quality of Life_Mental Component Scores (MCS)
timeFrame: 6 Months
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Professor, School of Nursing, Chang Gung University of Science and Technology
name: Su-Hui Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: