Trial Outcomes & Findings for Effects of a Mobile Application RA Joint Protection and Activity Self-management Program (NCT NCT05570175)
NCT ID: NCT05570175
Last Updated: 2025-01-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-01-13
Participant Flow
Participant milestones
| Measure |
Intervention Group
The intervention group received a mobile application RA joint protection and activity self-management program based on self-efficacy theory for 6 weeks.
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.
|
Control Group
The control group received general information on rheumatoid arthritis care and follow-up.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
21
|
|
Overall Study
COMPLETED
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of a Mobile Application RA Joint Protection and Activity Self-management Program
Baseline characteristics by cohort
| Measure |
Intervention Group
n=25 Participants
The intervention group received a mobile application RA joint protection and activity self-management program based on self-efficacy theory for 6 weeks.
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.
|
Control Group
n=21 Participants
The control group received general information on rheumatoid arthritis care and follow-up.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.84 years
STANDARD_DEVIATION 10.54 • n=5 Participants
|
62.1 years
STANDARD_DEVIATION 16.86 • n=7 Participants
|
58.70 years
STANDARD_DEVIATION 13.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
25 participants
n=5 Participants
|
21 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Duration of RA
|
9.06 years
STANDARD_DEVIATION 5.33 • n=5 Participants
|
14.33 years
STANDARD_DEVIATION 12.12 • n=7 Participants
|
11.47 years
STANDARD_DEVIATION 9.35 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksTo 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.
Outcome measures
| Measure |
Intervention Group
n=25 Participants
The intervention group received a mobile application RA joint protection and activity self-management program based on self-efficacy theory for 6 weeks.
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.
|
Control Group
n=21 Participants
The control group received general information on rheumatoid arthritis care and follow-up.
|
|---|---|---|
|
Self-management Behaviors
|
13.24 score on a scale
Standard Deviation 5.67
|
14.76 score on a scale
Standard Deviation 6.71
|
SECONDARY outcome
Timeframe: 12 weeksDisease 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.
Outcome measures
| Measure |
Intervention Group
n=25 Participants
The intervention group received a mobile application RA joint protection and activity self-management program based on self-efficacy theory for 6 weeks.
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.
|
Control Group
n=21 Participants
The control group received general information on rheumatoid arthritis care and follow-up.
|
|---|---|---|
|
Disease Activity
|
3.45 score on a scale
Standard Deviation 1.23
|
3.57 score on a scale
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: 12 weeksWe 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.
Outcome measures
| Measure |
Intervention Group
n=25 Participants
The intervention group received a mobile application RA joint protection and activity self-management program based on self-efficacy theory for 6 weeks.
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.
|
Control Group
n=21 Participants
The control group received general information on rheumatoid arthritis care and follow-up.
|
|---|---|---|
|
Arthritis Self-efficacy- Pain
|
24.08 score on a scale
Standard Deviation 13.47
|
24.38 score on a scale
Standard Deviation 16.63
|
SECONDARY outcome
Timeframe: 12 weeksWe 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.
Outcome measures
| Measure |
Intervention Group
n=25 Participants
The intervention group received a mobile application RA joint protection and activity self-management program based on self-efficacy theory for 6 weeks.
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.
|
Control Group
n=21 Participants
The control group received general information on rheumatoid arthritis care and follow-up.
|
|---|---|---|
|
Arthritis Self-efficacy- Other
|
30.48 score on a scale
Standard Deviation 15.75
|
33.00 score on a scale
Standard Deviation 16.51
|
SECONDARY outcome
Timeframe: 12 weeksThe 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.
Outcome measures
| Measure |
Intervention Group
n=25 Participants
The intervention group received a mobile application RA joint protection and activity self-management program based on self-efficacy theory for 6 weeks.
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.
|
Control Group
n=21 Participants
The control group received general information on rheumatoid arthritis care and follow-up.
|
|---|---|---|
|
Physical Functioning
|
23.32 score on a scale
Standard Deviation 4.34
|
23.10 score on a scale
Standard Deviation 2.97
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Su-Hui Chen
Chang Gung University of Science and Technology
Phone: 886-3-2118999
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place