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

Arthritis, Rheumatoid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05570175
• Other study ID #: ChangGungMHappRA
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: October 2022
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Behavioral:
• 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. The program was based on self-efficacy theory 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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-management behaviors	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'. Higher scores indicate a higher level of use of each of the self-management behavior. The range of the score will be 0-32.	12 weeks
Secondary	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.	12 weeks
Secondary	Arthritis Self-efficacy- pain	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 higher self-efficacy. This scale have 5 items, therefore, the score range will be 0-50.	12 weeks
Secondary	Arthritis Self-efficacy- other	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 higher self-efficacy. This scale have 6 items, therefore, the score range will be 0-60.	12 weeks
Secondary	Physical functioning	The 8-item Modified Health Assessment Questionnaire 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 greater ability to conduct daily activities. The range of the score will be 8-32.	12 weeks
Secondary	Taiwanese Depression Questionnaire (TDQ)	The 18-item Taiwanese Depression Questionnaire (TDQ) was used to measure the level of depression. Patients were guided to rate each item, scored from 0 (not at all) to 3 (always) and possible range of scores is 0 to 54.	12 weeks