Arthritis, Rheumatoid
Conditions
Keywords
self-management, self-efficacy, mobile application
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.
Interventions
BEHAVIORALMobile 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.
Sponsors
National Science and Technology Council, Taiwan
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The researcher who collected the data and the researcher who applied the intervention program was never the same.
Intervention model description
Participants were randomly assigned to experimental group who received a mobile application RA joint protection and activity self-management program based on self-efficacy theory for 6 weeks, and a control group receiving standard rheumatology care only.
Eligibility
Sex/Gender
ALL
Age
20 Months to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| Control Group The control group received general information on rheumatoid arthritis care and follow-up. | 21 |
| Total | 46 |
Baseline characteristics
| Characteristic | Intervention Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 55.84 years STANDARD_DEVIATION 10.54 | 62.1 years STANDARD_DEVIATION 16.86 | 58.70 years STANDARD_DEVIATION 13.98 |
| Duration of RA | 9.06 years STANDARD_DEVIATION 5.33 | 14.33 years STANDARD_DEVIATION 12.12 | 11.47 years STANDARD_DEVIATION 9.35 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 25 Participants | 21 Participants | 46 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Taiwan | 25 participants | 21 participants | 46 participants |
| Sex: Female, Male Female | 22 Participants | 17 Participants | 39 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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'. The range of the score will be 0-32, higher scores indicate a better level of use of each of the self-management behavior.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Self-management Behaviors | 13.24 score on a scale | Standard Deviation 5.67 |
| Control Group | Self-management Behaviors | 14.76 score on a scale | Standard Deviation 6.71 |
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 better self-efficacy. This scale have 6 items, therefore, the score range will be 0-60.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Arthritis Self-efficacy- Other | 30.48 score on a scale | Standard Deviation 15.75 |
| Control Group | Arthritis Self-efficacy- Other | 33.00 score on a scale | Standard Deviation 16.51 |
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 better self-efficacy. This scale have 5 items, therefore, the score range will be 0-50.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Arthritis Self-efficacy- Pain | 24.08 score on a scale | Standard Deviation 13.47 |
| Control Group | Arthritis Self-efficacy- Pain | 24.38 score on a scale | Standard Deviation 16.63 |
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Disease Activity | 3.45 score on a scale | Standard Deviation 1.23 |
| Control Group | Disease Activity | 3.57 score on a scale | Standard Deviation 0.81 |
Secondary
Physical Functioning
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Physical Functioning | 23.32 score on a scale | Standard Deviation 4.34 |
| Control Group | Physical Functioning | 23.10 score on a scale | Standard Deviation 2.97 |