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Effectiveness of Multidisciplinary Protocolised Interventions on IVT Non-adherence Rates (ADHERE)

2026年4月28日 更新者:Tan Cheng Sim Anna、Singapore Eye Research Institute

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

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.

研究概览

研究类型

介入性

注册 (估计的)

200

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Multidisciplinary protocolized intervention (MPI)

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).

CATs specific to AMD and DME will be used to measure QoL by collecting scores in various patient-informed domains. Lower scores at baseline, or a significant reduction in scores on follow-up visits in the various domains, will inform potential areas to address and tailor our MPI accordingly.

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).
安慰剂比较:Standard care
In the standard care arm, the treating clinician will be masked from the CAT scores and will use his/her own discretion when recommending the treatment regimen or when making any appropriate nurse or allied health referrals, independent of the CAT scores.
The CAT scores will be recorded by the clinical research coordinator at baseline and follow-up visits for comparison to the MPI arm.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Effectiveness of multidisciplinary protocolized intervention (MPI) in improving adherence to intravitreal (IVT) Injection.
大体时间:From 6 month to 18 months.

Adherence is defined as

  1. patient attends all follow-up appointments within 1 month of the planned follow up date, and
  2. patient receives IVT within 1 month of when the doctor recommends IVT. At each follow up time point, the study team will assess if the patient has been "adherent" or "non-adherent". If the patient does not visit the clinic or does not attend the scheduled study visit, phone calls will be made to determine reasons or barriers for adherence. A remote invitation to complete the CAT questionnaire will also be sent to these patients or if uncontactable, they will be approached and interviewed at their next clinical visit. For previously treated patients, adherence status up to 2 years prior to study enrolment for the time of IVT treatment will be recorded by the study team from medical records.
From 6 month to 18 months.

次要结果测量

结果测量
措施说明
大体时间
Comparison of CAT scores (Specific aim 2A) from the CAT questionnaire database
大体时间:Baseline, 6,12 and 18 month

CAT scores will be collected via a hybrid remote or in-clinic delivery method. At baseline, CATs will be administered in-clinic or via CAT links sent by WhatsApp to their contact number . At subsequent timepoints, relevant CAT links will be sent via a WhatsApp message to their designated contact number, to complete the questionnaire remotely on their own SMART device, before their appointment.

Those who are unable to complete CAT testing remotely will be given an additional opportunity to complete them in-clinic using an internet enabled tablet in person at their clinic visit with/without CRC assistance. The CAT scores will be assessed by clinical research coordinator.

Baseline, 6,12 and 18 month
Effectiveness of MPI in improvement of visual function
大体时间:Enrolment to 18 months
Visual function -Monocular and binocular presenting corrected VA and CS (Specific aim 2B) will be collected from the clinical records. If data are not present, the CRCs will conduct these tests on participants using standardized protocols.domain-specific CAT scores at each follow-up time point. Compared to those in standard care, patients in the MPI group will have improved VA and CS at each follow-up time point.
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.
大体时间:At the end of 18-month time point.
Disease free intervals as defined by the maximum IVT treatment interval where no disease activity recurrence is detected on OCT will be collected from clinical records and OCT images from the clinical database (Specific aim 2B).
At the end of 18-month time point.
The implementation outcomes of MPI through mixed method testing with interviews and questionnaires (Specific aim 3).
大体时间:6 to 15 months.

The PI, assisted by their Co-Is and collaborators, will identify eligible individuals for qualitative interviewing that will be performed with major stakeholders between 6 to 15 months timeline. These include the clinicians, nurses and the allied health specialists (OP, OT and SW) who will be involved in administering the MPI, and patients and care-givers who receive the MPI. Potential individuals will be contacted over email or phone call, and a trained study team will follow up on affirmative responses by obtaining written informed consent to carry out the following study procedures.

Semi-structured (1-on-1) interviews with the above key stakeholders will be conducted to explore their perspectives on barriers and enablers of integrating MPI into a Singapore public hospital for the management of nAMD and DME patients receiving IVT. Purposive and snowball sampling will be used to ensure all stakeholder groups are represented. Interviews will be conducted until no new data emerges.

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).
大体时间:Baseline and 18-month
The sample size required for cost-effectiveness analysis is usually larger than clinical studies as it involves estimating the joint distribution of patient outcomes and costs. Furthermore, power calculations require setting a willingness-to-pay threshold, which is not known for Singapore. However, as cost-effectiveness is more concerned with estimating effect size rather than hypothesis testing, it can still provide valuable information even if underpowered. Instead of confidence intervals, sensitivity analysis will be used to assess the range of estimated values.
Baseline and 18-month

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Anna CS Tan, PhD、Singapore Eye Research Institute (SERI)

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年4月1日

初级完成 (估计的)

2027年3月1日

研究完成 (估计的)

2028年9月1日

研究注册日期

首次提交

2026年3月31日

首先提交符合 QC 标准的

2026年4月28日

首次发布 (实际的)

2026年5月5日

研究记录更新

最后更新发布 (实际的)

2026年5月5日

上次提交的符合 QC 标准的更新

2026年4月28日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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