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
PROMise-Pilot
2 other identifiers
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2025
CompletedFirst Posted
Study publicly available on registry
May 13, 2025
CompletedStudy Start
First participant enrolled
June 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
May 13, 2025
April 1, 2025
1.5 years
May 5, 2025
May 5, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Number of outpatient rheumatological appointments in 1 year
To measure the percentage change in the number of outpatient rheumatological appointments in 1 year
1 Year
Study Arms (2)
PROMise Model of Care
EXPERIMENTALPatients 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 INTERVENTIONUsual care
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Bath Ankylosing Spondylitis Disease Activity Index score of \>4
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Singapore General Hospital
Singapore, Singapore, 169608, Singapore
Related Publications (2)
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.
PMID: 28511288BACKGROUNDKwan 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.
PMID: 31721427BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2025
First Posted
May 13, 2025
Study Start
June 1, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
May 1, 2027
Last Updated
May 13, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share