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CTRI Number  CTRI/2025/05/086295 [Registered on: 05/05/2025] Trial Registered Prospectively
Last Modified On: 04/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Screening
Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   Trials to improve adherence to referrals in a community based eye screening program in northern India 
Scientific Title of Study   Personalised phone calls and organised group transportation to improve access to community-based eye care services in Uttar Pradesh, India: A multi-stage individual and three-arm cluster RCT within an adaptive platform trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shalinder Sabherwal  
Designation  Director, Public Health and Projects 
Affiliation  Dr. Shroffs Charity Eye Hospital 
Address  5027, Kedarnath Road, Daryaganj, New Delhi-110002, India

New Delhi
DELHI
110002
India 
Phone  9910305208  
Fax    
Email  shalinder.sabherwal@sceh.net  
 
Details of Contact Person
Scientific Query  
Name  Dr Shalinder Sabherwal  
Designation  Director, Public Health and Projects 
Affiliation  Dr. Shroffs Charity Eye Hospital 
Address  5027, Kedarnath Road, Daryaganj, New Delhi-110002, India

New Delhi
DELHI
110002
India 
Phone  9910305208  
Fax    
Email  shalinder.sabherwal@sceh.net  
 
Details of Contact Person
Public Query  
Name  Dr Shalinder Sabherwal  
Designation  Director, Public Health and Projects 
Affiliation  Dr. Shroffs Charity Eye Hospital 
Address  5027, Kedarnath Road, Daryaganj, New Delhi-110002, India

New Delhi
DELHI
110002
India 
Phone  9910305208  
Fax    
Email  shalinder.sabherwal@sceh.net  
 
Source of Monetary or Material Support  
Dr Shroffs Charity Eye Hospital 5027, Kedarnath Lane, Daryaganj New Delhi 110002 
 
Primary Sponsor  
Name  Dr Shroffs Charity Eye Hospital  
Address  5027 Kedarnath Lane Delhi 11002 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shalinder Sabherwal  Dr Shroffs Charity Eye Hospital   Department of Public Health Village Sahdeva, Gola Shahjahanpur Road, Mohammadi, Lakhimpur Kheri, Utar Pradesh, India,Pin Code 262804 Kheri UTTAR PRADESH
Kheri
UTTAR PRADESH 		 9910305208

shalinder.sabherwal@sceh.net 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SCEH Scientific Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  PICO  Population Adults (18 years) screened in a community based eye-screening programme by Dr Shroffs Charity Eye Hospital, and referred to the hospital for additional care but had not attended their referral appointment. The intervention is comprised of two components: (i) personalised phone calls to those who missed their initial appointments, offering them a second appointment, and (ii) the provision of transportation from the intervention villages to the vision centre for those who did not attend after receiving the phone call offering them a second appointment. The provision of transportation will be cluster (village) randomized and delivered either free of charge, or at standard rates. Comparator Usual care: standard SMS reminder messages to those referred for onward care with no transportation offered. Outcome - Probability of accessing treatment clinic.  
Comparator Agent  Usual Care / No Follow Up Call/ No Transport   The Comparator Agent in this study is: Usual Care – which consists of standard SMS reminder messages sent to participants referred for eye care. No personalized phone calls or organized transportation are offered in the comparator arm. This applies to both phases of the trial: In the phone call RCT: Comparator is no follow-up call (usual SMS reminder only). In the transportation RCT: Comparator is no transport offered (standard practice). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Referred after being screened in a community-based screening program 
 
ExclusionCriteria 
Details  Those who refuse to come to Shroffs facility at the time of screening itself and those who have severe mobility issues and are not capable of travel. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Other 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome measure is the proportion of attendance. We aim to identify an intervention that yields approximately 10% improvement on attendance compared to the control arm.  The primary outcome measure is the proportion of attendance. We aim to identify an intervention that yields approximately 10% improvement on attendance compared to the control arm. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL   
 
Target Sample Size   Total Sample Size="4500"
Sample Size from India="4500" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/04/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study evaluates whether personalized follow-up phone calls and organized transportation improve attendance at referral appointments among adults identified with eye care needs during community-based screening in Uttar Pradesh, India. It uses a two-stage randomized controlled trial design within an adaptive platform. The first stage tests the effectiveness of phone calls in increasing clinic attendance. The second stage assesses the impact of providing transportation—either free or at standard fare—among those who still do not attend after receiving a phone call. The aim is to improve access to care for underserved populations by testing low-risk, scalable service modifications. 
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