OsteoarthritisNCT05634304
Effect of a Patient-Centered Mobile App Self-Management Program for Osteoarthritis
A study testing A mobile app self-management (mSM) program in people with Osteoarthritis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Aim: The aim of this study is to develop and evaluate the efficacy of a mobile app self-management (mSM) program focusing on patients' needs in OA patients over a 6 months' follow-up. Methods: This study will be conducted in three years. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- A mobile app self-management (mSM) program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2019to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged 45 years more with primary or secondary diagnosis of OA
- At a clinically stable with no signs of disease exacerbation in the last 30 days
- Ability to use and learn app for mobile phone
Who cannot join
- With severe comorbidities such as metastatic disease, pathological fractures, infection, or acute trauma
- Unstable physical and terminal illnesses
- Severe cognitive impairments or another debilitating psychiatric disorder
- Contraindication to physical activity such as walking
- Participation in another research protocol
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, 33303
Junghua SHAO, PhD, +88632118800, shao@mail.cgu.edu.tw
Junghua SHAO, +88632118800, shao@mail.cgu.edu.tw
About this study
Official title: MyOsteoarthritisMyWay: Needs Exploring, Program Developing, and Implementing of a Patient-Centered Mobile App Self-Management Program for Osteoarthritis
Aim: The aim of this study is to develop and evaluate the efficacy of a mobile app self-management (mSM) program focusing on patients' needs in OA patients over a 6 months' follow-up.
Methods: This study will be conducted in three years. In the first year, a qualitative needs assessment will be conducted to explore 20 parents' needs for improvements of the SM program until the saturation is reached. The specific requirements of the mSM users based on the parents' needs will be identified. In the second year, after patients' needs identified, the mSM program focusing on patients' needs will be developed through the literature searched and experts consulted. The mSM program contents, prototype, mobile application, field usability, and user acceptance will be tested by a 4-month pilot study. To ensure the protocol is realistic and whether any modifications of the program procedure are required by running pilot study with 10 OA patients. In the third year, we will test a patient-needs mobile app SM program for OA by randomized controlled trial of 6 months' duration. The total 66 patients with OA will be recruited while the participant in orthopedics clinic of a hospital. The experimental group (N=33) will receive a mSM program, and the control group (N=33) will receive with the usual care only. In order to examine the effects of mSM program, data will be collected with 4 time points which will be conducted at baseline (pre-discharge hospital) and at 1, 3, and 6 months, and by seven health- related outcomes that include physical function, quality of OA care, self-efficacy, quality of life, SM behaviors, and health services use. Outcome measures of this study will be analyzed using descriptive and inferential statistics with the generalized estimating equations analysis.
Read the detailed description
Background: Osteoarthritis (OA) is a progressively degenerative disease, and is a leading cause of disability with incidence and prevalence rising in most elderly populations which contribute the number of OA continue increasing at a rapid rate. Indeed, the symptoms of OA can cause disability, pain, and joint stiffness, even results poorer quality of life. Self-management (SM) is worldwide reported as an effective approach to utilize for those with chronic disease. However, we had been conducted a program that granted by the Ministry of Science and Technology (NSC 102-2628-B-182-019-MY3), which showed the traditional SM program have some limitation such as patients can't get help immediately, follow up the patients' needs, fraud issue, involving all patients because geographical barriers, and the effectiveness don't remain long term. Therefore, it is need to develop of scalable eHealth SM models and practices seems mandatory in order to cope with the change in population needs and reduce the burden of OA. Aim: The aim of this study is to develop and evaluate the efficacy of a mobile app self-management (mSM) program focusing on patients' needs in OA patients over a 6 months' follow-up.
Methods: This study will be conducted in three years. In the first year, a qualitative needs assessment will be conducted to explore 20 parents' needs for improvements of the SM program until the saturation is reached. The specific requirements of the mSM users based on the parents' needs will be identified. In the second year, after patients' needs identified, the mSM program focusing on patients' needs will be developed through the literature searched and experts consulted. The mSM program contents, prototype, mobile application, field usability, and user acceptance will be tested by a 4-month pilot study. To ensure the protocol is realistic and whether any modifications of the program procedure are required by running pilot study with 10 OA patients. In the third year, we will test a patient-needs mobile app SM program for OA by randomized controlled trial of 6 months' duration. The total 66 patients with OA will be recruited while the participant in orthopedics clinic of a hospital. The experimental group (N=33) will receive a mSM program, and the control group (N=33) will receive with the usual care only. The mSM program is developed on Bundura's self-efficacy theory, which provides four sources of information for SM. The strategies of the mSM consist of mobile app to management program including peer support, appraisal, goal setting and self-monitoring of exercise for OA and symptom management. In order to examine the effects of mSM program, data will be collected with 4 time points which will be conducted at baseline (pre-discharge hospital) and at 1, 3, and 6 months, and by seven health- related outcomes that include physical function, quality of OA care, self-efficacy, quality of life, SM behaviors, and health services use. Outcome measures of this study will be analyzed using descriptive and inferential statistics with the generalized estimating equations analysis.
- Conditions
- Osteoarthritis
- Being tested
- A mobile app self-management (mSM) program
- Keywords
- osteoarthritis, self-management, mobile app, self-efficacy
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A mobile app self-management (mSM) programBehavioural
The mSM program is developed on Bundura's self-efficacy theory, which provides four sources of information for SM. The strategies of the mSM consist of mobile app to management program including peer support, appraisal, goal setting and self-monitoring of exercise for OA and symptom management.
| Study group | Role | What they receive |
|---|---|---|
| The mobile app self-management (mSM) program focusing on patients' needs in OA patients | Experimental | An individualized mobile app self-management (mSM) program for managing OA 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 OA situations. Receives: Behavioral: A mobile app self-management (mSM) program |
| Control group for mSM program | No intervention | The control group will receive with the usual care only and follow-up 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
OsteoArthritis Quality Indicator (OA-QI) questionnaire version 2 (v2)
The OA-QI v2 is a joint specific outcome measure tool designed to assess patient-reported quality of OA care and to provide quality indicator in pass rates. Each item has three response option with 'Yes', 'No' and a third response which item is not applicable (for example, 'Not overweight' for the items on weight management) or the participant do not remember in 16 QI items. Scoring involves summating the total for each item score between 0-100, with a higher score indicating greater disability.
Measured: 6 months
Arthritis Self-efficacy Scale (ASE)
The 11-items ASE scale is made up of two subscale including "ASE: Pain" and "ASE: Other Symptoms" will be used in current study. The research subjects will be asked to respond using a visual analogue scales (1-10) ranging from 1 "very uncertain", to 10 "very certain". Scores are summed across the items for each subscale to give a total score with a range of 5-50 for ASE- Pain (5 items), and 6-60 for ASE- Other Symptoms (6 items), with higher scores indicating higher confidence in arthritis self-efficacy.
Measured: 6 months
Self-management behaviors scale
Cognitive symptom managements will assess using scales with each item rated in a six-point scale (0-5) anchored by "never" and "always". Scoring involves summating the total for each item score between 0-30, with a higher score indicating greater behaviors of self-management.
Measured: 6 months
Secondary outcomes (4)
EuroQol 5 Dimensions, European Quality of Life Five Dimension, and EuroQol five-dimensional. (EQ-5D-5L)
The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (VAS). The descriptive system comprises five dimensions: The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state, for example, scoring 1 being the best score with no problem. A higher score in the EQ-5D-5L indicated better the quality of life. Moreover, the EQ visual analogue scale (VAS) is a measure of overall self-rated health status for TODAY. Scoring involves summating the total for each item score between 0-100, with a higher score indicating good their health.
Measured: 6 months
Sit-to-stand. 30 second chair stand test
A test of sit-to-stand activity. Also a test of lower body strength and dynamic balance. On the signal to begin, start the stop watch. Count the total number of chair stands (up and down equals one stand) completed in 30 seconds. If a full stand has been completed at 30 seconds (i.e. standing fully erect or on the way down to the sitting position), then this final stand is counted in the total. If a person cannot stand even once then the score for the test is zero. The maximum number of chair stand repetitions possible in a 30 second period.
Measured: 6 months
Walking short distances. 4x10m fast-paced walk test
A test of short distance walking activity. Scoring as below:
- Timing starts on the signal to start at the start line and terminates once the participant crosses back over the start line after completing the 40 m (4x10 m).
- When the participant crosses the 10m mark, timing is paused whilst the participant turns around the cone and then is resumed once they cross the 10m mark again. The same is repeated for the following turns and is stopped once the participant crosses the start line for the final time.
- Time of one trial is recorded to the nearest 100th of a second.
- Time of one test trial is recorded and expressed as speed m/s by dividing distance (40m) by time (s).
- Regular walking aid is allowed and use should be recorded.
- Minimal reporting standards: Assistive devices such as usual walking aids - walking stick et.
Measured: 6 months
Health services use
Health services use will be measured from the self-reported number of contacts with a general physician, orthopedist, and other medical specialists including clinical and emergency visits as well as hospitalizations on all patients.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start1 Aug 2019
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- In the third year, we will test a patient-needs mobile app SM program for OA by randomized controlled trial of 6 months' duration. The total 66 patients with OA will be recruited while the participant in orthopedics clinic of a hospital. The experimental group (N=33) will receive a mSM program, and the control group (N=33) will receive with the usual care only.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council
- Responsible party
- Sponsor
- Investigators
- Junghua SHAO, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634304
- Sponsor's protocol ID
- ChangGungMHOA
- Status last verified
- Nov 2022
- First submitted
- 9 Nov 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: NO yet
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyOsteoarthritisMyWay: Needs Exploring, Program Developing, and Implementing of a Patient-Centered Mobile App Self-Management Program for Osteoarthritis
- ClinicalTrials.gov ID
- NCT05634304
- Acronym / sponsor ID
- ChangGungMHOA
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, self-management, mobile app, self-efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim: The aim of this study is to develop and evaluate the efficacy of a mobile app self-management (mSM) program focusing on patients' needs in OA patients over a 6 months' follow-up.
Methods: This study will be conducted in three years. In the first year, a qualitative needs assessment will be conducted to explore 20 parents' needs for improvements of the SM program until the saturation is reached. The specific requirements of the mSM users based on the parents' needs will be identified. In the second year, after patients' needs identified, the mSM program focusing on patients' needs will be developed through the literature searched and experts consulted. The mSM program contents, prototype, mobile application, field usability, and user acceptance will be tested by a 4-month pilot study. To ensure the protocol is realistic and whether any modifications of the program procedure are required by running pilot study with 10 OA patients. In the third year, we will test a patient-needs mobile app SM program for OA by randomized controlled trial of 6 months' duration. The total 66 patients with OA will be recruited while the participant in orthopedics clinic of a hospital. The experimental group (N=33) will receive a mSM program, and the control group (N=33) will receive with the usual care only. In order to examine the effects of mSM program, data will be collected with 4 time points which will be conducted at baseline (pre-discharge hospital) and at 1, 3, and 6 months, and by seven health- related outcomes that include physical function, quality of OA care, self-efficacy, quality of life, SM behaviors, and health services use. Outcome measures of this study will be analyzed using descriptive and inferential statistics with the generalized estimating equations analysis.
Detailed description
Background: Osteoarthritis (OA) is a progressively degenerative disease, and is a leading cause of disability with incidence and prevalence rising in most elderly populations which contribute the number of OA continue increasing at a rapid rate. Indeed, the symptoms of OA can cause disability, pain, and joint stiffness, even results poorer quality of life. Self-management (SM) is worldwide reported as an effective approach to utilize for those with chronic disease. However, we had been conducted a program that granted by the Ministry of Science and Technology (NSC 102-2628-B-182-019-MY3), which showed the traditional SM program have some limitation such as patients can't get help immediately, follow up the patients' needs, fraud issue, involving all patients because geographical barriers, and the effectiveness don't remain long term. Therefore, it is need to develop of scalable eHealth SM models and practices seems mandatory in order to cope with the change in population needs and reduce the burden of OA. Aim: The aim of this study is to develop and evaluate the efficacy of a mobile app self-management (mSM) program focusing on patients' needs in OA patients over a 6 months' follow-up.
Methods: This study will be conducted in three years. In the first year, a qualitative needs assessment will be conducted to explore 20 parents' needs for improvements of the SM program until the saturation is reached. The specific requirements of the mSM users based on the parents' needs will be identified. In the second year, after patients' needs identified, the mSM program focusing on patients' needs will be developed through the literature searched and experts consulted. The mSM program contents, prototype, mobile application, field usability, and user acceptance will be tested by a 4-month pilot study. To ensure the protocol is realistic and whether any modifications of the program procedure are required by running pilot study with 10 OA patients. In the third year, we will test a patient-needs mobile app SM program for OA by randomized controlled trial of 6 months' duration. The total 66 patients with OA will be recruited while the participant in orthopedics clinic of a hospital. The experimental group (N=33) will receive a mSM program, and the control group (N=33) will receive with the usual care only. The mSM program is developed on Bundura's self-efficacy theory, which provides four sources of information for SM. The strategies of the mSM consist of mobile app to management program including peer support, appraisal, goal setting and self-monitoring of exercise for OA and symptom management. In order to examine the effects of mSM program, data will be collected with 4 time points which will be conducted at baseline (pre-discharge hospital) and at 1, 3, and 6 months, and by seven health- related outcomes that include physical function, quality of OA care, self-efficacy, quality of life, SM behaviors, and health services use. Outcome measures of this study will be analyzed using descriptive and inferential statistics with the generalized estimating equations analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- In the third year, we will test a patient-needs mobile app SM program for OA by randomized controlled trial of 6 months' duration. The total 66 patients with OA will be recruited while the participant in orthopedics clinic of a hospital. The experimental group (N=33) will receive a mSM program, and the control group (N=33) will receive with the usual care only.
| Arm | Type | Receives |
|---|---|---|
| The mobile app self-management (mSM) program focusing on patients' needs in OA patients | Experimental | Behavioral: A mobile app self-management (mSM) programAn individualized mobile app self-management (mSM) program for managing OA 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 OA situations. |
| Control group for mSM program | No intervention | –The control group will receive with the usual care only and follow-up 6 months. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants aged 45 years more with primary or secondary diagnosis of OA
- At a clinically stable with no signs of disease exacerbation in the last 30 days
- Ability to use and learn app for mobile phone
Key exclusion criteria (5 listed)
- With severe comorbidities such as metastatic disease, pathological fractures, infection, or acute trauma
- Unstable physical and terminal illnesses
- Severe cognitive impairments or another debilitating psychiatric disorder
- Contraindication to physical activity such as walking
- Participation in another research protocol
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 |
|---|---|---|
| A mobile app self-management (mSM) programThe mSM program is developed on Bundura's self-efficacy theory, which provides four sources of information for SM. The strategies of the mSM consist of mobile app to management program including peer support, appraisal, goal setting and self-monitoring of exercise for OA and symptom management. | Behavioural | The mobile app self-management (mSM) program focusing on patients' needs in OA patients |
Primary outcome
OsteoArthritis Quality Indicator (OA-QI) questionnaire version 2 (v2)
Time frame: 6 months
The OA-QI v2 is a joint specific outcome measure tool designed to assess patient-reported quality of OA care and to provide quality indicator in pass rates. Each item has three response option with 'Yes', 'No' and a third response which item is not applicable (for example, 'Not overweight' for the items on weight management) or the participant do not remember in 16 QI items. Scoring involves summating the total for each item score between 0-100, with a higher score indicating greater disability.
Arthritis Self-efficacy Scale (ASE)
Time frame: 6 months
The 11-items ASE scale is made up of two subscale including "ASE: Pain" and "ASE: Other Symptoms" will be used in current study. The research subjects will be asked to respond using a visual analogue scales (1-10) ranging from 1 "very uncertain", to 10 "very certain". Scores are summed across the items for each subscale to give a total score with a range of 5-50 for ASE- Pain (5 items), and 6-60 for ASE- Other Symptoms (6 items), with higher scores indicating higher confidence in arthritis self-efficacy.
Self-management behaviors scale
Time frame: 6 months
Cognitive symptom managements will assess using scales with each item rated in a six-point scale (0-5) anchored by "never" and "always". Scoring involves summating the total for each item score between 0-30, with a higher score indicating greater behaviors of self-management.
4 secondary outcomes
EuroQol 5 Dimensions, European Quality of Life Five Dimension, and EuroQol five-dimensional. (EQ-5D-5L)
Time frame: 6 months
Sit-to-stand. 30 second chair stand test
Time frame: 6 months
Walking short distances. 4x10m fast-paced walk test
Time frame: 6 months
Health services use
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Individual participant dataSharing planned: No. NO yet
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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.
Junghua SHAO principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A mobile app self-management (mSM) program in people with Osteoarthritis, 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junghua SHAO, PhD (886-3-2118800 ext. 5481, shao@mail.cgu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OsteoArthritis Quality Indicator (OA-QI) questionnaire version 2 (v2) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Dec 2022; AzTrials last refreshed its copy on 4 Nov 2026.