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Clinical Trials/NCT05570175
NCT05570175
Completed
N/A

Effectiveness of Mobile Application Self-management Program (App) for Joint Protection and Physical Activity in Patients With Rheumatoid Arthritis

Chang Gung Memorial Hospital1 site in 1 country46 target enrollmentAugust 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Arthritis, Rheumatoid
Sponsor
Chang Gung Memorial Hospital
Enrollment
46
Locations
1
Primary Endpoint
Self-management Behaviors
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
July 31, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Self-management Behaviors

Time Frame: 12 weeks

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'. The range of the score will be 0-32, higher scores indicate a better level of use of each of the self-management behavior.

Secondary Outcomes

  • Arthritis Self-efficacy- Pain(12 weeks)
  • Arthritis Self-efficacy- Other(12 weeks)
  • Physical Functioning(12 weeks)
  • Disease Activity(12 weeks)

Study Sites (1)

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