Clinical trial NCT05570175: Effects of a Mobile Application RA Joint Protection and Activity Self-management Program
Official title: Effectiveness of Mobile Application Self-management Program (App) for Joint Protection and Physical Activity in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis, Rheumatoid
Keywords: self-management, self-efficacy, mobile application
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2022-10-06
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Standard ages: CHILD
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 mobile application RA joint protection and activity self-management program based on self-efficacy theory for 6 weeks, and a control group receiving standard rheumatology care only.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to evaluate the effectiveness of mobile application self-management program (App) for joint protection and physical activity in patients with rheumatoid arthritis. Intervention group received an app self-management program. The researchers compared the effects of the experimental group and the control group in disease activity, physical functioning, self-efficacy, depression, and self-management behavior.

Detailed description: Rheumatoid arthritis (RA) is a persistent systemic disease. 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, the evidences from literature presented that there are some limitations in traditional self-management interventions, and a comprehensive rheumatoid arthritis online self-management program for RA patients' day-to-day self-managing is limited in Taiwan. The goal of this clinical trial is to evaluate the effectiveness of mobile application self-management program (App) for joint protection and physical activity in patients with rheumatoid arthritis. The project was designed to implement and evaluate the app rheumatoid arthritis self-management program for RA patients using two groups experimental design. A medical center in northern Taiwan was selected and patients who visited the RA departments were eligible for the study if they are diagnosis of RA, age of 20 years or over, disease considered by the treating rheumatologist to have been stable for at least 12 weeks, able to communicate with researcher, and use a mobile. Patients were excluded if they are suffering from other terminal illnesses, severe dementia or another debilitating psychiatric disorder, or living in a long-term care facility. After completion of baseline data, patients were 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 received the 6-week app rheumatoid arthritis self-management program which based on self-efficacy theory. The independent variable of the program was 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 were followed up for 6 months, and the data were collected at the baseline, 8, and 12 weeks. The statistics with the generalized estimating equation analysis was used to evaluate the outcomes such as the disease activity (DAS-28), arthritis self-efficacy (ASE), physical functioning (MHAQ), depression, and self-management behaviors.

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
* Use a mobile

Exclusion Criteria:

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

Primary outcomes:
measure: Self-management Behaviors
timeFrame: 12 weeks
Secondary outcomes:
measure: Disease Activity
timeFrame: 12 weeks
measure: Arthritis Self-efficacy- Pain
timeFrame: 12 weeks
measure: Arthritis Self-efficacy- Other
timeFrame: 12 weeks
measure: Physical Functioning
timeFrame: 12 weeks
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: