Effectiveness of Multidisciplinary Protocolised Interventions on IVT Non-adherence Rates

Summary

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.

Conditions

• Diabetic Macular Edema
• Neovascular (Wet) Age-Related Macular Degeneration
• Intravitreal Injection

Interventions

BEHAVIORAL

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).

BEHAVIORAL

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.

Sponsors & Collaborators

• Singapore National Eye Centre

  collaborator OTHER_GOV

• Singapore Eye Research Institute

  lead OTHER

Principal Investigators

• Anna CS Tan, PhD · Singapore Eye Research Institute (SERI)

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-30

Primary Completion

2027-03-31

Completion

2028-09-30