Trial Outcomes & Findings for Effects of a Rheumatoid Arthritis Self-management Program (NCT NCT03470740)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

224 participants

Primary outcome timeframe

6 months

Results posted on

2025-08-22

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Group An individualized home-based rheumatoid arthritis self-management program for managing RA patients' physical behavioral problems was applied for the intervention group. The program was based on the self-efficacy theory and the four resources were incorporated to emphasize patients' knowledge, skill, and responsibility in managing their RA situations. rheumatoid arthritis self-management program: The intervention group received the rheumatoid arthritis self-management program which was based on Bandura's theory of self-efficacy 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	112	112
Overall Study COMPLETED	108	106
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group n=112 Participants An individualized home-based rheumatoid arthritis self-management program for managing RA patients' physical behavioral problems was applied for the intervention group. The program was based on the self-efficacy theory and the four resources were incorporated to emphasize patients' knowledge, skill, and responsibility in managing their RA situations. rheumatoid arthritis self-management program: The intervention group received the rheumatoid arthritis self-management program which was based on Bandura's theory of self-efficacy 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=112 Participants The control group received general information on rheumatoid arthritis care and follow-up.	Total n=224 Participants Total of all reporting groups
Age, Continuous	58.20 years STANDARD_DEVIATION 11.29 • n=112 Participants	59.47 years STANDARD_DEVIATION 11.86 • n=112 Participants	58.83 years STANDARD_DEVIATION 11.57 • n=224 Participants
Sex: Female, Male Female	94 Participants n=112 Participants	98 Participants n=112 Participants	192 Participants n=224 Participants
Sex: Female, Male Male	18 Participants n=112 Participants	14 Participants n=112 Participants	32 Participants n=224 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Taiwan	112 participants n=112 Participants	112 participants n=112 Participants	224 participants n=224 Participants
Duration of RA	10.21 years STANDARD_DEVIATION 8.09 • n=112 Participants	11.12 years STANDARD_DEVIATION 8.92 • n=112 Participants	10.66 years STANDARD_DEVIATION 8.51 • n=224 Participants

PRIMARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure	Intervention Group n=112 Participants An individualized home-based rheumatoid arthritis self-management program for managing RA patients' physical behavioral problems was applied for the intervention group. The program was based on the self-efficacy theory and the four resources were incorporated to emphasize patients' knowledge, skill, and responsibility in managing their RA situations. rheumatoid arthritis self-management program: The intervention group received the rheumatoid arthritis self-management program which was based on Bandura's theory of self-efficacy 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=112 Participants The control group received general information on rheumatoid arthritis care and follow-up.
Disease Activity	3.38 score on a scale Standard Deviation 1.15	3.62 score on a scale Standard Deviation 1.26

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure	Intervention Group n=112 Participants An individualized home-based rheumatoid arthritis self-management program for managing RA patients' physical behavioral problems was applied for the intervention group. The program was based on the self-efficacy theory and the four resources were incorporated to emphasize patients' knowledge, skill, and responsibility in managing their RA situations. rheumatoid arthritis self-management program: The intervention group received the rheumatoid arthritis self-management program which was based on Bandura's theory of self-efficacy 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=112 Participants The control group received general information on rheumatoid arthritis care and follow-up.
Arthritis Self-efficacy- Pain	35.21 score on a scale Standard Deviation 8.86	32.72 score on a scale Standard Deviation 11.16

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure	Intervention Group n=112 Participants An individualized home-based rheumatoid arthritis self-management program for managing RA patients' physical behavioral problems was applied for the intervention group. The program was based on the self-efficacy theory and the four resources were incorporated to emphasize patients' knowledge, skill, and responsibility in managing their RA situations. rheumatoid arthritis self-management program: The intervention group received the rheumatoid arthritis self-management program which was based on Bandura's theory of self-efficacy 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=112 Participants The control group received general information on rheumatoid arthritis care and follow-up.
Arthritis Self-efficacy- Other	51.71 score on a scale Standard Deviation 8.98	48.96 score on a scale Standard Deviation 11.88

SECONDARY outcome

Timeframe: 6 months

The Short-form 36 includes one multi-item scale that assesses 8 dimensions of health: physical functioning (PF), social functioning (SF), role limitations because of physical health problems (RP), bodily pain (BP), general mental health (psychological distress and well-being; MH), limitations in usual role activities because of emotional problems (RE), vitality (energy and fatigue; VT), and general health perceptions (GH), was used to assess the quality of life in this study. The original scale using the Likert scoring method, the score is from 1-3 or 1-5. Before the scores are added, we follow the SF-36 manual, adjust each item scored from 0 to 100, with 0 indicating extreme problems and 100 indicating no problems. The physical component scores (PCS) included GH, PF, RP, and BP, then the scores of each sub-question under the Physical Component Scores are summed together, and the range after adjustment from 0 (extreme problems) to 400 (no problems) for the Physical Component Scores.

Outcome measures

Outcome measures
Measure	Intervention Group n=112 Participants An individualized home-based rheumatoid arthritis self-management program for managing RA patients' physical behavioral problems was applied for the intervention group. The program was based on the self-efficacy theory and the four resources were incorporated to emphasize patients' knowledge, skill, and responsibility in managing their RA situations. rheumatoid arthritis self-management program: The intervention group received the rheumatoid arthritis self-management program which was based on Bandura's theory of self-efficacy 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=112 Participants The control group received general information on rheumatoid arthritis care and follow-up.
SF-36 Quality of life_Physical Component Scores	51.29 score on a scale Standard Deviation 8.72	48.88 score on a scale Standard Deviation 10.23

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure	Intervention Group n=112 Participants An individualized home-based rheumatoid arthritis self-management program for managing RA patients' physical behavioral problems was applied for the intervention group. The program was based on the self-efficacy theory and the four resources were incorporated to emphasize patients' knowledge, skill, and responsibility in managing their RA situations. rheumatoid arthritis self-management program: The intervention group received the rheumatoid arthritis self-management program which was based on Bandura's theory of self-efficacy 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=112 Participants The control group received general information on rheumatoid arthritis care and follow-up.
Physical Functioning	23.72 score on a scale Standard Error 7.30	26.14 score on a scale Standard Error 10.64

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure	Intervention Group n=112 Participants An individualized home-based rheumatoid arthritis self-management program for managing RA patients' physical behavioral problems was applied for the intervention group. The program was based on the self-efficacy theory and the four resources were incorporated to emphasize patients' knowledge, skill, and responsibility in managing their RA situations. rheumatoid arthritis self-management program: The intervention group received the rheumatoid arthritis self-management program which was based on Bandura's theory of self-efficacy 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=112 Participants The control group received general information on rheumatoid arthritis care and follow-up.
Self-management Behaviors	16.69 score on a scale Standard Deviation 4.80	16.24 score on a scale Standard Deviation 4.82

SECONDARY outcome

Timeframe: 6 Months

The Short-form 36 includes one multi-item scale that assesses 8 dimensions of health: physical functioning (PF), social functioning (SF), role limitations because of physical health problems (RP), bodily pain (BP), general mental health (psychological distress and well-being; MH), limitations in usual role activities because of emotional problems (RE), vitality (energy and fatigue; VT), and general health perceptions (GH), was used to assess the quality of life in this study. The original scale using the Likert scoring method, the score is from 1-3 or 1-5. Before the scores are added, we follow the SF-36 manual, adjust each item scored from 0 to 100, with 0 indicating extreme problems and 100 indicating no problems. The mental component scores (MCS) included RE, SF, VT, and MH, then the scores of each sub-question under the Mental Component Scores are summed together, and the range after adjustment from 0 (extreme problems) to 400 (no problems) for the Mental Component Scores.

Outcome measures

Outcome measures
Measure	Intervention Group n=112 Participants An individualized home-based rheumatoid arthritis self-management program for managing RA patients' physical behavioral problems was applied for the intervention group. The program was based on the self-efficacy theory and the four resources were incorporated to emphasize patients' knowledge, skill, and responsibility in managing their RA situations. rheumatoid arthritis self-management program: The intervention group received the rheumatoid arthritis self-management program which was based on Bandura's theory of self-efficacy 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=112 Participants The control group received general information on rheumatoid arthritis care and follow-up.
SF-36 Quality of Life_Mental Component Scores (MCS)	50.98 score on a scale Standard Deviation 9.36	48.97 score on a scale Standard Deviation 10.67

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