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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PROMise Model of Care.
- Who it may be relevant to
- Registry conditions: Axial Spondyloarthritis. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Singapore
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Procedure PROMise 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.
Primary outcome measures
- Number of outpatient rheumatological appointments in 1 year [Time frame: 1 Year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Singapore · 1 center
- Singapore General Hospital — Singapore
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. PMID 28511288
- Kwan 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 PMID 31721427
Identifiers
NCT: NCT06968247 · 2024-4044 · AM/HRT048/2025 (SRDUKAMR25H8)