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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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06968247
Acronym
PROMise-Pilot
Enrollment
70
Registered
2025-05-13
Start date
2025-06-30
Completion date
2027-05-31
Last updated
2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Axial Spondyloarthritis

Brief 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 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.

Interventions

PROCEDUREPROMise Model of Care

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.

Sponsors

Singapore General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Bath Ankylosing Spondylitis Disease Activity Index score of \>4

Design outcomes

Primary

MeasureTime frameDescription
Number of outpatient rheumatological appointments in 1 year1 YearTo measure the percentage change in the number of outpatient rheumatological appointments in 1 year

Countries

Singapore

Contacts

Primary ContactYu Heng Kwan, BSc(Pharm)(Hons), MD, PhD
yuheng.kwan@mohh.com.sg+65 90231226
Backup ContactXin Ru Chew, BSc(Science)(Hons)
chew.xin.ru@sgh.com.sg+65 98791992

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026