Arthritis, RheumatoidNCT05570175
Effects of a Mobile Application RA Joint Protection and Activity Self-management Program
A study testing Mobile application RA joint protection and activity self-management program in people with Arthritis, Rheumatoid, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 months and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Mobile application RA joint protection and activity self-management program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2021to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Suffering from other terminal illnesses, severe dementia or another debilitating psychiatric disorder
- Living in a long-term care facility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Mobile Application Self-management Program (App) for Joint Protection and Physical Activity in Patients With Rheumatoid Arthritis
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.
Read the 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.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Mobile application RA joint protection and activity self-management program
- Keywords
- self-management, self-efficacy, mobile application
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile application RA joint protection and activity self-management programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | The intervention group received a mobile application RA joint protection and activity self-management program based on self-efficacy theory for 6 weeks. Receives: Behavioral: Mobile application RA joint protection and activity self-management program |
| control group | No intervention | The control group received general information on rheumatoid arthritis care and follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (4)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Aug 2021
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Su-Hui Chen, PhD, Principal investigator, Professor, School of Nursing, Chang Gung University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570175
- Sponsor's protocol ID
- ChangGungMHappRA
- Status last verified
- Oct 2022
- First submitted
- 4 Oct 2022
- Last updated
- 13 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shao JH, Yu KH, Kao YC, Liang YC, Chen SH. Effects of a Smartphone App-Based Intervention on Rheumatoid Arthritis Self-Management Efficacy: A Randomized Controlled Trial. J Nurs Res. 2024 Oct 1;32(5):e349. doi: 10.1097/jnr.0000000000000638.
PubMed 39514777
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mobile Application Self-management Program (App) for Joint Protection and Physical Activity in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT05570175
- Acronym / sponsor ID
- ChangGungMHappRA
- Conditions
- Arthritis, Rheumatoid
- Keywords
- self-management, self-efficacy, mobile application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 6 Oct 2022 (actual)
- Results
- Posted 13 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Mobile application RA joint protection and activity self-management programThe intervention group received a mobile application RA joint protection and activity self-management program based on self-efficacy theory for 6 weeks. |
| control group | No intervention | –The control group received general information on rheumatoid arthritis care and follow-up. |
Who may qualify
- Ages
- 20 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Suffering from other terminal illnesses, severe dementia or another debilitating psychiatric disorder
- Living in a long-term care facility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile application RA joint protection and activity self-management programThe 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. | Behavioural | intervention group |
Primary outcome
Self-management Behaviors
Time frame: 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.
4 secondary outcomes
Disease Activity
Time frame: 12 weeks
Arthritis Self-efficacy- Pain
Time frame: 12 weeks
Arthritis Self-efficacy- Other
Time frame: 12 weeks
Physical Functioning
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39514777Shao JH, Yu KH, Kao YC, Liang YC, Chen SH. Effects of a Smartphone App-Based Intervention on Rheumatoid Arthritis Self-Management Efficacy: A Randomized Controlled Trial. J Nurs Res. 2024 Oct 1;32(5):e349. doi: 10.1097/jnr.0000000000000638.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Su-Hui Chen, PhD principal investigator
Professor, School of Nursing, Chang Gung University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile application RA joint protection and activity self-management program in people with Arthritis, Rheumatoid, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-management Behaviors (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05570175, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.