NCT07611682

Brief Summary

This cluster randomized controlled trial aims to evaluate the effectiveness of a Structured Referral Tracking (SRT) intervention in improving referral completion among adults identified with avoidable blindness during community-based eye screening camps in Rawalpindi District, Pakistan. Ten community clusters will be randomized into intervention and control groups. Participants in the intervention group will receive structured referral counseling, weekly reminder calls or messages, and customized referral guidance for eight weeks, while the control group will receive standard referral procedures. The primary outcome is referral completion at a tertiary eye hospital within eight weeks after screening. Secondary outcomes include knowledge regarding avoidable blindness, treatment satisfaction, feasibility, acceptability, and barriers influencing referral completion.

Trial Health

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Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Jun 2026

Shorter than P25 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 Progress8%
Jun 2026Nov 2026

First Submitted

Initial submission to the registry

May 13, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Expected
Last Updated

June 4, 2026

Status Verified

June 1, 2026

Enrollment Period

Same day

First QC Date

May 13, 2026

Last Update Submit

June 2, 2026

Conditions

Keywords

Community Eye ScreeningAvoidable BlindnessCataractRefractive ErrorDiabetic RetinopathyReferral SystemStructured Referral Tracking

Outcome Measures

Primary Outcomes (1)

  • Referral Completion Rate Verified Through Hospital Records

    Proportion of referred participants who complete referral visits at the tertiary eye hospital, verified through hospital attendance records.

    Within 8 weeks after community eye screening

Secondary Outcomes (3)

  • Knowledge Score on Avoidable Blindness Questionnaire

    Baseline and 8 weeks after screening

  • Participant Acceptability of Structured Referral Tracking Assessed Using Structured Feedback Questionnaire

    Within 8 weeks after screening

  • Barriers Influencing Referral Completion Assessed Using Structured Barrier Assessment Questionnaire

    Within 8 weeks after screening

Other Outcomes (2)

  • Participant Treatment Satisfaction Score Using Structured Satisfaction Questionnaire

    Within 8 weeks after screening

  • Feasibility of Structured Referral Tracking Assessed by Reminder Delivery and Follow-up Completion Rates

    Within 8 weeks after screening

Study Arms (2)

Structured Referral Tracking (SRT)

EXPERIMENTAL

Participants will receive structured referral counseling, weekly reminder calls or messages, visual educational material, and customized referral guidance for eight weeks following community-based eye screening.

Behavioral: Structured Referral Tracking (SRT)

Standard Referral Procedure

NO INTERVENTION

Participants will receive routine referral slips and standard counseling without structured follow-up or reminder communication.

Interventions

A multi-component referral tracking intervention including referral counseling, weekly reminder calls or mobile messages, visual educational material, and customized referral guidance to improve referral completion after community eye screening.

Structured Referral Tracking (SRT)

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18 years or above
  • Individuals diagnosed with visual impairment or eye conditions requiring referral to a tertiary eye care facility
  • Permanent residents of Rawalpindi District, Pakistan
  • Willing and able to provide informed consent

You may not qualify if:

  • Individuals already undergoing treatment for the identified eye condition
  • Individuals requiring emergency ophthalmic care
  • Severe systemic or physical illness limiting follow-up
  • Individuals unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ACCO Department, Al-Shifa Trust Eye Hospital, Rawalpindi

Rawalpindi, Punjab Province, 46600, Pakistan

Location

Related Publications (3)

  • Harwood M, Cunningham W. Lessons from 2020 for equity in global eye health. Lancet Glob Health. 2021 Apr;9(4):e387-e388. doi: 10.1016/S2214-109X(21)00036-X. Epub 2021 Feb 16. No abstract available.

    PMID: 33607017BACKGROUND
  • World Health Organization. Blindness and visual impairment. Geneva: World Health Organization; 2023

    BACKGROUND
  • Khan AA, Talpur KI, Awan Z, Arteaga SL, Bolster NM, Katibeh M, Watts E, Bastawrous A. Improving equity, efficiency and adherence to referral in Pakistan's eye health programmes: Pre- and post-pandemic onset. Front Public Health. 2022 Jul 22;10:873192. doi: 10.3389/fpubh.2022.873192. eCollection 2022.

Related Links

MeSH Terms

Conditions

CataractRefractive ErrorsDiabetic Retinopathy

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRetinal DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Dr. Ahmad Abdullah, PHD

    Shifa International Hospital, Islamabad

    STUDY DIRECTOR

Central Study Contacts

Khizar Nabeel, PHD (In progress)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors and data analysts will remain blinded to cluster allocation during data collection and statistical analysis. Intervention and control groups will be coded using neutral identifiers until completion of primary analysis.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Community clusters (union councils) will be randomized into intervention and control arms. Participants within each cluster will receive the same referral procedure according to cluster allocation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Khizar Nabeel

Study Record Dates

First Submitted

May 13, 2026

First Posted

May 28, 2026

Study Start

June 1, 2026

Primary Completion

June 1, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

June 4, 2026

Record last verified: 2026-06

Locations