NCT04800718

Brief Summary

Background: Vision Centre (primary eyecare facility): a major eye care service model catering to underserved rural areas. The sustainability of rural Vision Centres (VC) in north India is a major challenge due to the under-utilization of services by the local community and stakeholders. This affects self-sustainability and limits the expansion of services in rural areas. Dr. Shroff's Charity Eye Hospital is planning an intervention: door-to-door screening in VC's vicinity areas, to connect with the community. In this operational research, the investigators plan to study if this intervention package, consisting of door-to-door screening and awareness generation in the service area can increase the utilization of VC services to a minimum of 14 out-patient cases per day within the study period and also analyze its cost-effectiveness for scalability. Methodology: The study is a randomized experimental intervention, consisting of 2 VCs (intervention arm and control arm) selected from poor low-performing VCs i.e. walk-in out-patient cases≤ 10 per day, in two operational regions (Vrindavan, Mathura District, and Mohammadi, Kheri District) of Uttar Pradesh. Intervention includes door-to-door screening and awareness generation in 8-12 villages surrounding the VC. The control VC will follow existing practices of awareness generation through community activities and health talks. Data collected from each VC for the 4 months of intervention will include, a number of walk-in patients, spectacles advised, and their uptake, referral, and uptake for cataract and specialty surgery as well as operational expenses. Differences across arms in terms of the number of walk-in patients, referrals, uptake of services, and costs involved would be analyzed. Conclusion: Through this study, the investigators would analyze if our intervention package is effective in increasing the VC service utilization and thus, overall sustainability. The investigators would also study the cost-effectiveness of this intervention, to assess its scalability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2021

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

9 months

First QC Date

March 10, 2021

Last Update Submit

March 9, 2022

Conditions

Keywords

Vision CentresEye care AwarenessDoor-to-Door screeningVisual Acuity

Outcome Measures

Primary Outcomes (1)

  • Increase in numbers of walk in patients at VC from baseline

    Increase in numbers of walk in patients at VC from baseline 7-8 walk in patients to 14 per day after the intervention period of four months

    4 months

Secondary Outcomes (2)

  • Uptake of services

    3 months

  • Cost-effectiveness

    3 months

Study Arms (2)

Door-to-door screening

EXPERIMENTAL

Intervention includes door-to-door screening and awareness generation in 8-12 villages surrounding the Vision Centres

Other: Intervention Arm

Routine awareness activities,Control Arm

NO INTERVENTION

The control arm VC will continue its routine awareness activities \& health talk sessions in the community.

Interventions

Intervention includes door-to-door screening and awareness generation in 8-12 villages surrounding the Vision Centres

Also known as: door-to-door screening and awareness generation
Door-to-door screening

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • VCs were included based on the following criteria:
  • Low performance (walk-in OPD ≤ 10/day)
  • Duration of operation \>1 year
  • Presence of 1 VC in each arm from selected VCs

You may not qualify if:

  • VCs with a walk-in OPD greater than 10 per day \& those in operation for less than one year were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SCEH

New Delhi, India

Location

Related Publications (1)

  • Sabherwal S, Chinnakaran A, Sood I, Garg GK, Singh BP, Shukla R, Reddy PA, Gilbert S, Bassett K, Murthy GVS; Operational Research Capacity Building Study Group. Effect of Door-to-Door Screening and Awareness Generation Activities in the Catchment Areas of Vision Centers on Service Use: Protocol for a Randomized Experimental Study. JMIR Res Protoc. 2021 Nov 4;10(11):e31951. doi: 10.2196/31951.

MeSH Terms

Conditions

Eye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The intervention will include door-to-door screening and awareness generation in 8-12 villages surrounding VC and control VC will follow existing practices of awareness generation through community activities and health talks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 16, 2021

Study Start

February 22, 2021

Primary Completion

November 30, 2021

Study Completion

December 30, 2021

Last Updated

March 10, 2022

Record last verified: 2022-03

Locations