- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07611682
Community-Based Eye Screening With Structured Referral Tracking for Preventing Avoidable Blindness in Adults in Rawalpindi, Pakistan (SIGHT)
Community-Based Eye Screening With a Structured Referral Tracking Intervention for the Prevention of Avoidable Blindness Among Adults in Rawalpindi District, Pakistan
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Avoidable blindness remains a major public health challenge in low- and middle-income countries, including Pakistan. Community-based eye screening camps are commonly used to identify individuals with visual impairment and eye diseases requiring treatment; however, referral completion to tertiary eye care facilities remains poor. Many patients fail to attend referral hospitals because of limited awareness, lack of follow-up, transportation barriers, and uncertainty regarding treatment procedures.
This study aims to evaluate the effectiveness and implementation 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.
The study will use a cluster randomized controlled trial design. Ten community clusters (union councils) from five tehsils of Rawalpindi District will be selected using multistage random sampling. Clusters will be randomized into intervention and control arms. Participants attending eye screening camps who are diagnosed with eye conditions requiring referral to a tertiary eye hospital will be enrolled after informed consent.
Participants in the intervention arm will receive a multi-component Structured Referral Tracking intervention consisting of referral counseling, weekly reminder calls or mobile messages, visual educational material, and customized referral guidance regarding hospital location, estimated costs, and required documents. Participants in the control arm will receive standard referral procedures consisting of routine counseling and referral slips without structured follow-up.
The primary outcome will be referral completion at the tertiary eye hospital within eight weeks after screening, verified through hospital attendance records. Secondary outcomes will include knowledge regarding avoidable blindness, treatment satisfaction, feasibility and acceptability of the intervention, and barriers influencing referral completion.
The findings of this study are expected to provide evidence regarding the effectiveness and feasibility of structured referral tracking systems for improving eye care service utilization and reducing avoidable blindness in Pakistan.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Khizar Nabeel, PHD (In progress)
- Número de teléfono: +923455096776
- Correo electrónico: khizar@hsa.edu.pk
Ubicaciones de estudio
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Punjab Province
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Rawalpindi, Punjab Province, Pakistán, 46600
- ACCO Department, Al-Shifa Trust Eye Hospital, Rawalpindi
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Structured Referral Tracking (SRT)
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.
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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.
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Sin intervención: Standard Referral Procedure
Participants will receive routine referral slips and standard counseling without structured follow-up or reminder communication.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Referral Completion Rate Verified Through Hospital Records
Periodo de tiempo: Within 8 weeks after community eye screening
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Proportion of referred participants who complete referral visits at the tertiary eye hospital, verified through hospital attendance records.
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Within 8 weeks after community eye screening
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Knowledge Score on Avoidable Blindness Questionnaire
Periodo de tiempo: Baseline and 8 weeks after screening
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Participant knowledge regarding avoidable blindness and eye health assessed using a structured questionnaire developed for the study.
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Baseline and 8 weeks after screening
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Participant Acceptability of Structured Referral Tracking Assessed Using Structured Feedback Questionnaire
Periodo de tiempo: Within 8 weeks after screening
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Participant acceptability of the Structured Referral Tracking intervention assessed using a structured feedback questionnaire regarding usefulness and satisfaction with reminder communication.
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Within 8 weeks after screening
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Barriers Influencing Referral Completion Assessed Using Structured Barrier Assessment Questionnaire
Periodo de tiempo: Within 8 weeks after screening
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Barriers and facilitators influencing referral completion assessed using a structured questionnaire among referred participants.
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Within 8 weeks after screening
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Participant Treatment Satisfaction Score Using Structured Satisfaction Questionnaire
Periodo de tiempo: Within 8 weeks after screening
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Participant-reported satisfaction regarding referral services and treatment received at the tertiary eye hospital assessed using a structured satisfaction questionnaire.
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Within 8 weeks after screening
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Feasibility of Structured Referral Tracking Assessed by Reminder Delivery and Follow-up Completion Rates
Periodo de tiempo: Within 8 weeks after screening
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Feasibility of the intervention assessed through successful delivery of reminder messages/calls and completion of scheduled follow-up procedures.
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Within 8 weeks after screening
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Dr. Ahmad Abdullah, PHD, Shifa International Hospital, Islamabad
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- World Health Organization. Blindness and visual impairment. Geneva: World Health Organization; 2023
- 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.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- hsa2026135
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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