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NCT Number: NCT06968247

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PROMise Model of Care

Procedure

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 outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Xin Ru Chew, BSc(Science)(Hons)

CONTACT

[email protected]

+65 98791992

Yu Heng Kwan, BSc(Pharm)(Hons), MD, PhD

CONTACT

[email protected]

+65 90231226

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Registry information

Acronym: PROMise-Pilot

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 13, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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