Effectiveness of Multidisciplinary Protocolised Interventions on IVT Non-adherence Rates

Официальное название

The Effectiveness of Multidisciplinary Protocolised Interventions to Reduce Non-adherencE Rates (ADHERE) in Patients With Chronic Macula Diseases Receiving Intravitreal Injections: A Randomised Controlled Trial

Обзор

The purpose of this research study is to test whether a personalised care approach improves adherence compared to standard care. Many patients with macular diseases like age-related macular degeneration and diabetic macular edema need regular eye injections to protect their vision. However, some do not adhere to their treatment appointments, risking further vision loss. You were selected as a possible participant in this research study because you have been diagnosed with neovascular age-related macular degeneration (nAMD) or diabetic macula edema (DME) requiring intravitreal injection treatment (IVT). This research study targets to recruit 200 participants from the Singapore National Eye Centre. This study comprises two cohort groups: Cohort 1(Suboptimal CAT scores/ Randomized Control trial) and Cohort 2 (Optimal CAT scores/Observation). If you agree to take part in this study, the research coordinator will obtain your written consent before proceeding with the study procedures. You will be required to complete CAT assessment (via remote or administered in clinic) and assigned to cohort 1 or cohort 2 based on CAT scores result. If you are assigned to cohort 1, you will be randomly allocated to either the personalized multi-disciplinary protocolized intervention (MPI) or standard care group. Randomization means assigning you to one of two groups by chance, like tossing a coin or rolling a dice. * MPI group: You will complete a specialized computerized adaptive testing (CAT) quality of life questionnaire. Based on the domain specific scores, you will receive a medical consultation and a referral to nurse educators, optometrists, occupational therapists, or social workers. * Standard care group: If you are allocated to this group, you will receive standard care, where doctors make treatment decisions without using the CAT results. If you are assigned to cohort 2, you will be placed under prospective observation and undergo routine clinical care.

Вмешательства

• Поведенческое multidisciplinary protocolized intervention (MPI)
  Our novel proposed approach to improve adherence to IVT is personalized patient-centred care comprising a multidisciplinary protocolized intervention (MPI), which consists of medical consultation, to optimize the treatment regimen, and combinations of appropriate referrals to either (1) a nurse-directed patient education program (NE), (2) a low vision optometrist (OP), (3) an occupational therapy services (OT) and/or (4) a medical social worker (SW).
• Поведенческое Routine medical care & monitoring
  The CAT scores will be recorded by the clinical research coordinator at baseline and follow-up visits for comparison to the MPI arm.

Первичные конечные точки

• Effectiveness of multidisciplinary protocolized intervention (MPI) in improving adherence to intravitreal (IVT) Injection. [Срок оценки: From 6 month to 18 months.]

Вторичные конечные точки (5)

• Comparison of CAT scores (Specific aim 2A) from the CAT questionnaire database [Срок оценки: Baseline, 6,12 and 18 month]
• Effectiveness of MPI in improvement of visual function [Срок оценки: Enrolment to 18 months]
• Effectiveness of MPI in increasing disease-free intervals in patients with nAMD or DME receiving IVT and having suboptimal CAT scores. [Срок оценки: At the end of 18-month time point.]
• The implementation outcomes of MPI through mixed method testing with interviews and questionnaires (Specific aim 3). [Срок оценки: 6 to 15 months.]
• To assess the cost-effectiveness of the MPI for improving adherence to IVT, considering its potential impact on long term visual acuity (VA) loss and QoL adjusted years (QALYs). [Срок оценки: Baseline and 18-month]

Критерии участия

Критерии включения

• Patients with chronic macula disease including those diagnosed with nAMD and DME, who require IVT.
• This would include treatment naive patients (no IVT in either eye the last 6 months) and previously treated patients who have had IVT in either eye in the last 6 months and require further IVT treatment at the baseline study visit in either eye.
• Able to provide informed consent and must consent to undergoing the MPI intervention.
• Speak English or Mandarin.
• Must be a Singapore resident.

Критерии исключения

• Patients who are unwilling or unable to perform CAT testing.
• Unable to provide informed consent.
• Significant eye pathology such as cornea problems, glaucoma, or other retinal diseases that may substantially affect vision.
• Do not speak English or Mandarin fluently.
• Cognitive impairment (as assessed using 6CIT).
• Obvious observable physical or hearing disabilities that prevents them from completing the CAT questionnaire and undergoing MPI effectively.

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

Двойное слепое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07567898 · MOH-001922-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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