Axial SpondyloarthritisPROMise-PilotNCT06968247
Assessing the Feasibility of the Patient-Reported Outcomes Based Model for Community Care of Patients With Axial Spondyloarthritis Via a Type 1 Pilot Hybrid Effectiveness-Implementation Trial Using the RE-AIM Framework
A study testing PROMise Model of Care in people with Axial Spondyloarthritis, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
The goal of this clinical trial is to facilitate the implementation of PROMs-based care for patients with axial spondyloarthritis. The main questions it aims to answer are: What are the barriers, facilitators and strategies to implement PROMs-based care? Can the PROMise algorithm successfully review and postpone… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- PROMise Model of Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSingapore
- Study dates
- Jun 2025to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with axial spondyloarthritis according to the 2009 ASAS Classification Criteria of AxSpA
- has been receiving care in Singapore General Hospital for at least 6 months
- aged 21 years and above
Who cannot join
- Bath Ankylosing Spondylitis Disease Activity Index score of >4
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site
Singapore General Hospital
Singapore, Singapore, 169608
Xin Ru Chew, BSc(Science)(Hons), +65 98791992, chew.xin.ru@sgh.com.sg
Yu Heng Kwan, BSc(Pharm)(Hons), MD, PhD, +65 90231226, yuheng.kwan@mohh.com.sg
About this study
The goal of this clinical trial is to facilitate the implementation of PROMs-based care for patients with axial spondyloarthritis.
The main questions it aims to answer are:
Read more
- What are the barriers, facilitators and strategies to implement PROMs-based care?
- Can the PROMise algorithm successfully review and postpone appointments of eligible patients?
- How feasible is PROMs-based care in patients with axial spondyloarthritis?
Researchers will implement PROMs-Based care and see if PROMs-Based care is feasible and understand patient's opinions on PROMs-Based care implemented.
Participants will:
- Be randomized to either receive intervention (PROM-based care) or control (usual care). Randomisation means assigning you to one of two groups by chance, like tossing a coin or rolling dice.
- That receive PROMs-based care, will be sent PROMs questionnaires that ask them about their health conditions via SMS at a regular interval of 4 months.
- Have their appointments postponed by 4 months, if the PROMise algorithm with specific thresholds (with overview from the rheumatology care team) assess their condition as stable through their blood test results and PROMs questionnaire.
- Have a cap of 12 months between physician visits.
- Conditions
- Axial Spondyloarthritis
- Being tested
- PROMise Model of Care
- Medical subject headings
- Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROMise Model of CareProcedure or surgery
Patients will go for blood tests and be sent PROMs questionnaire prior to planned clinic appointments. The results of the blood tests and questionnaire will be reviewed by a physician. The physician will postpone patient's appointment if the patient is assessed as stable. Any physician-endorsed medication will be sent via a medication delivery service.
| Study group | Role | What they receive |
|---|---|---|
| PROMise Model of Care | Experimental | Patients will go for blood tests and be sent PROMs questionnaire prior to planned clinic appointments. The results of the blood tests and questionnaire will be reviewed by a physician. The physician will postpone patient's appointment if the patient is assessed as stable. Any physician-endorsed medication will be sent via a medication delivery service. Receives: Procedure: PROMise Model of Care |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of outpatient rheumatological appointments in 1 year
To measure the percentage change in the number of outpatient rheumatological appointments in 1 year
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study startJun 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Singapore General 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968247
- Sponsor's protocol ID
- 2024-4044
- Other IDs
- AM/HRT048/2025 (SRDUKAMR25H8)
- Acronym
- PROMise-Pilot
- Status last verified
- Apr 2025
- First submitted
- 5 May 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Thurah A, Stengaard-Pedersen K, Axelsen M, Fredberg U, Schougaard LMV, Hjollund NHI, Pfeiffer-Jensen M, Laurberg TB, Tarp U, Lomborg K, Maribo T. Tele-Health Followup Strategy for Tight Control of Disease Activity in Rheumatoid Arthritis: Results of a Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2018 Mar;70(3):353-360. doi: 10.1002/acr.23280. Epub 2018 Jan 23.
PubMed 28511288Kwan YH, Tan JJ, Phang JK, Fong W, Lim KK, Koh HL, Lui NL, Tan CS, Ostbye T, Thumboo J, Leung YY. Validity and reliability of the Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in patients with axial spondyloarthritis (axSpA) in Singapore. Int J Rheum Dis. 2019 Dec;22(12):2206-2212. doi: 10.1111/1756-185X.13735. Epub 2019 Nov 13.
PubMed 31721427
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility of the Patient-Reported Outcomes Based Model for Community Care of Patients With Axial Spondyloarthritis Via a Type 1 Pilot Hybrid Effectiveness-Implementation Trial Using the RE-AIM Framework
- ClinicalTrials.gov ID
- NCT06968247
- Acronym / sponsor ID
- PROMise-Pilot / 2024-4044
- Conditions
- Axial Spondyloarthritis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 13 May 2025 (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.
The goal of this clinical trial is to facilitate the implementation of PROMs-based care for patients with axial spondyloarthritis.
The main questions it aims to answer are:
- What are the barriers, facilitators and strategies to implement PROMs-based care?
- Can the PROMise algorithm successfully review and postpone appointments of eligible patients?
- How feasible is PROMs-based care in patients with axial spondyloarthritis?
Researchers will implement PROMs-Based care and see if PROMs-Based care is feasible and understand patient's opinions on PROMs-Based care implemented.
Participants will:
- Be randomized to either receive intervention (PROM-based care) or control (usual care). Randomisation means assigning you to one of two groups by chance, like tossing a coin or rolling dice.
- That receive PROMs-based care, will be sent PROMs questionnaires that ask them about their health conditions via SMS at a regular interval of 4 months.
- Have their appointments postponed by 4 months, if the PROMise algorithm with specific thresholds (with overview from the rheumatology care team) assess their condition as stable through their blood test results and PROMs questionnaire.
- Have a cap of 12 months between physician visits.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROMise Model of Care | Experimental | Procedure: PROMise Model of CarePatients will go for blood tests and be sent PROMs questionnaire prior to planned clinic appointments. The results of the blood tests and questionnaire will be reviewed by a physician. The physician will postpone patient's appointment if the patient is assessed as stable. Any physician-endorsed medication will be sent via a medication delivery service. |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed with axial spondyloarthritis according to the 2009 ASAS Classification Criteria of AxSpA
- has been receiving care in Singapore General Hospital for at least 6 months
- aged 21 years and above
Key exclusion criteria (1 listed)
- Bath Ankylosing Spondylitis Disease Activity Index score of >4
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 |
|---|---|---|
| PROMise Model of CarePatients will go for blood tests and be sent PROMs questionnaire prior to planned clinic appointments. The results of the blood tests and questionnaire will be reviewed by a physician. The physician will postpone patient's appointment if the patient is assessed as stable. Any physician-endorsed medication will be sent via a medication delivery service. | Procedure or surgery | PROMise Model of Care |
Primary outcome
Number of outpatient rheumatological appointments in 1 year
Time frame: 1 Year
To measure the percentage change in the number of outpatient rheumatological appointments in 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Background: PubMed 28511288de Thurah A, Stengaard-Pedersen K, Axelsen M, Fredberg U, Schougaard LMV, Hjollund NHI, Pfeiffer-Jensen M, Laurberg TB, Tarp U, Lomborg K, Maribo T. Tele-Health Followup Strategy for Tight Control of Disease Activity in Rheumatoid Arthritis: Results of a Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2018 Mar;70(3):353-360. doi: 10.1002/acr.23280. Epub 2018 Jan 23.
- Background: PubMed 31721427Kwan YH, Tan JJ, Phang JK, Fong W, Lim KK, Koh HL, Lui NL, Tan CS, Ostbye T, Thumboo J, Leung YY. Validity and reliability of the Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in patients with axial spondyloarthritis (axSpA) in Singapore. Int J Rheum Dis. 2019 Dec;22(12):2206-2212. doi: 10.1111/1756-185X.13735. Epub 2019 Nov 13.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROMise Model of Care in people with Axial Spondyloarthritis, run by Singapore General Hospital at 1 site in Singapore.
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 1 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: opening soon, as of the sponsor's last update on 13 May 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 Singapore. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Heng Kwan, BSc(Pharm)(Hons), MD, PhD (+65 90231226, yuheng.kwan@mohh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of outpatient rheumatological appointments in 1 year (time frame: 1 Year). 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 NCT06968247, which also lists 2 linked publications.
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 May 2025.