Effectiveness of Multidisciplinary Protocolised Interventions on IVT Non-adherence Rates

NCT07567898 | Not Yet Recruiting DMC

• 1 other identifier: MOH-001922-00
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

ADHERE, Macular diseases, Intravitreal injections.; neovascular age-related macular

Outcome Measures

Primary Outcomes (1)

• Effectiveness of multidisciplinary protocolized intervention (MPI) in improving adherence to intravitreal (IVT) Injection.

  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.

Secondary Outcomes (5)

• Comparison of CAT scores (Specific aim 2A) from the CAT questionnaire database

  Baseline, 6,12 and 18 month

• Effectiveness of MPI in improvement of visual function

  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.

  At the end of 18-month time point.

• The implementation outcomes of MPI through mixed method testing with interviews and questionnaires (Specific aim 3).

  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).

  Baseline and 18-month

Study Arms (2)

Multidisciplinary protocolized intervention (MPI)

ACTIVE COMPARATOR

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.

Behavioral: multidisciplinary protocolized intervention (MPI)

Standard care

PLACEBO COMPARATOR

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.

Behavioral: Routine medical care & monitoring

Interventions

multidisciplinary protocolized intervention (MPI) BEHAVIORAL

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).

Multidisciplinary protocolized intervention (MPI)

Routine medical care & monitoring BEHAVIORAL

The CAT scores will be recorded by the clinical research coordinator at baseline and follow-up visits for comparison to the MPI arm.

Standard care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Singapore Eye Research Institute: lead
• Singapore National Eye Centre: collaborator

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Anna CS Tan, PhD

  Singapore Eye Research Institute (SERI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Tan CS Clinical Associate Professor, PhD

CONTACT

+65-63227424; anna.tan.c.s@singhealth.com.sg

NEO WT Clinical Research Coordinator, Diploma

CONTACT

+65-90584081; neo.wee.teck@seri.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Co-Is who are not the treating clinicians.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study comprises two arms- Multidisciplinary protocolized intervention (MPI) versus Standard care arm. Intervention for MPI arm with sub-optimal CAT scores 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).

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: May 5, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share