NCT07333248

Brief Summary

This operational research project aims to strengthen continuity of eye care delivery between community screening and hospital-based treatment in rural Assam by redesigning referral pathways from the Boko Eye Care Center (ECC) to Sri Sankaradeva Nethralaya (SSDN) base hospital. Despite active outreach in the Boko region from the Boko ECC through conducting regular outreach screenings, less than 30 percent of patients referred to the base hospital actually arrive for evaluation and less than 25 percent of those advised for surgery proceed to treatment. The proposed study addresses these gaps by examining behavioural, structural and logistical barriers to referral completion and surgical uptake, and by implementing a coordinated patient-centered referral and engagement strategy. The proposed intervention comprises of five sequential components: (1) root cause analysis to identify bottlenecks and facilitators in the current referral pathway, (2) community engagement activities to improve awareness and proactive health-seeking behaviour, (3) implementation of an integrated referral and engagement model supported by trained community team and structured referral tracking, (4) strengthening referral completion through patient navigation, scheduled transport and follow-up reminders, and (5) enhancement of surgical acceptance through standardized counseling, affordability support and social reinforcement. The outcomes will be measured prospectively, focusing on increase in hospital footfall from the Boko catchment area, proportion of referred patients who complete hospital visits, and proportion of patients who were advised for surgery and had undergone the procedure. The proposed project aims to achieve a minimum of 70 percent referral completion and 45 percent surgical conversion by the end of the 36-month study period.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Feb 2026Jan 2028

First Submitted

Initial submission to the registry

December 30, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

January 12, 2026

Status Verified

December 1, 2025

Enrollment Period

12 months

First QC Date

December 30, 2025

Last Update Submit

December 30, 2025

Conditions

Keywords

Referral completionCataract surgery uptakePatient navigationCommunity engagementRural eye careSurgical acceptanceAssamLMIC

Outcome Measures

Primary Outcomes (1)

  • Referral completion rate to base hospital

    Referral completion rate to base hospital

    36 months

Secondary Outcomes (1)

  • Surgical conversion rate among patients advised for surgery

    36 months

Other Outcomes (1)

  • Increase in overall hospital footfall originating from Boko catchment area

    36 months

Study Arms (1)

Referral and Engagement

EXPERIMENTAL

Referral tracking, patient navigation, community awareness tools, standardized counseling, transport and financial facilitation mechanisms

Other: Experimental: Integrated Referral and Engagement Model

Interventions

Referral tracking, patient navigation, community awareness tools, standardized counseling, transport and financial facilitation mechanisms

Referral and Engagement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults diagnosed with eye conditions requiring referral or surgical treatment.

You may not qualify if:

  • Patients requiring emergency treatment, patients medically unfit for surgery, or patients unwilling to participate.
  • Eligibility: Enrolment criteria: Participants will be enrolled consecutively at the time of screening in community outreach camps and at the Boko Eye Care Center if they meet the following operational criteria:
  • i. Adult (≥18 years) with a diagnosed eye condition requiring referral to Sri Sankaradeva Nethralaya for tertiary evaluation or surgical treatment, as determined by the examining optometrist/ophthalmologist.
  • ii. Resident of the Boko Eye Care Center catchment area (villages linked to the Eye Care Center under Sri Sankaradeva Nethralaya outreach).
  • iii. Patients willing to provide informed consent to participate in the study and to allow follow-up for referral completion and surgical acceptance outcomes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sri Sankaradeva Nethralaya

Guwahati, Assam, 781028, India

Location

MeSH Terms

Conditions

CataractRefractive Errors

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Priya Adisesha Reddy

    Seva Canada Society

    STUDY DIRECTOR

Central Study Contacts

Dr Harsha Bhattacharjee

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2025

First Posted

January 12, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2028

Last Updated

January 12, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations