Effectiveness of Multidisciplinary Protocolised Interventions on IVT Non-adherence Rates

Official title

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

Overview

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.

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.

Primary outcome measures

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

Secondary outcome measures (5)

• Comparison of CAT scores (Specific aim 2A) from the CAT questionnaire database [Time frame: Baseline, 6,12 and 18 month]
• Effectiveness of MPI in improvement of visual function [Time frame: 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. [Time frame: At the end of 18-month time point.]
• The implementation outcomes of MPI through mixed method testing with interviews and questionnaires (Specific aim 3). [Time frame: 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). [Time frame: Baseline and 18-month]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07567898 · MOH-001922-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗