Effects of a Mobile Application RA Joint Protection and Activity Self-management Program

Not Applicable

Completed

Conditions: Arthritis, Rheumatoid

Interventions: Behavioral: Mobile application RA joint protection and activity self-management program

Registration Number: NCT05570175

Lead Sponsor: Chang Gung Memorial Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 46

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	Mobile application RA joint protection and activity self-management program	The intervention group received a mobile application RA joint protection and activity self-management program based on self-efficacy theory for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Self-management Behaviors	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 Outcome Measures

Name	Time	Method
Arthritis Self-efficacy- Pain	12 weeks	We used the arthritis self-efficacy-pain (ASE-pain) to measure RA patients' pain self-efficacy. The ASE-pain used visual analogue scales (0-10), in which 0 means 'very uncertain' and 10 means 'very certain'; a higher score refers to better self-efficacy. This scale have 5 items, therefore, the score range will be 0-50.
Arthritis Self-efficacy- Other	12 weeks	We used the arthritis self-efficacy-other (ASE-OS) to measure RA patients' other symptoms self-efficacy. The ASE-OS used visual analogue scales (0-10), in which 0 means 'very uncertain' and 10 means 'very certain'; a higher score refers to better self-efficacy. This scale have 6 items, therefore, the score range will be 0-60.
Physical Functioning	12 weeks	The 8-item Modified Health Assessment Questionnaire (MHAQ) was used to measure the physical functioning for this study. The MHAQ measures eight activities such as dressing and grooming, arising, eating, walking, hygiene, reach grip, and common daily activities. Items are rated from 1 = without difficulty, to 4 = unable to do; a lower score indicates a better ability to conduct daily activities. The range of the score will be 8-32.
Disease Activity	12 weeks	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.