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

Обзор

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.

Вмешательства

• Процедура 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.

Первичные конечные точки

• Number of outpatient rheumatological appointments in 1 year [Срок оценки: 1 Year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Bath Ankylosing Spondylitis Disease Activity Index score of >4

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Сингапур · 1 центр

• Singapore General Hospital — Singapore

Публикации

• 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

Идентификаторы

NCT: NCT06968247 · 2024-4044 · AM/HRT048/2025 (SRDUKAMR25H8)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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