To Investigate the Feasibility and Acceptability of Trained Non-medical Professionals Performing Laser Treatment for Proliferative Diabetic Retinopathy (PDR), and the Potential Impact on Service Capacity. Assess Feasibility of Conducting a Full Trial Comparing Trained ECPs With Ophthalmologists (Avenue-PDR)
Assessing the Viability of Non-medical Practitioners Conducting Photocoagulation for PDR (AVENUE-PDR): A Feasibility Trial
To Investigate the Feasibility and Acceptability of Trained Non-medical Professionals Performing Laser Treatment for Proliferative Diabetic Retinopathy (PDR), and the Potential Impact on Service Capacity.
To assess Feasibility of Conducting a Full Trial Comparing Trained ECPs With Ophthalmologists in performing laser treatment in line with the established protocols.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Swansea, Reino Unido
- Reclutamiento
- Swansea Bay University Health Board: Ophthalmology Department, Singleton Hospital
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Contacto:
- Mahmoud Mr Awad
- Número de teléfono: +44 1792 285034
- Correo electrónico: mahmoud.awad@wales.nhs.uk
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- People with diabetes
- Proliferative diabetic retinopathy
- Aged18 years or over
- New referrals
Exclusion Criteria:
- Follow up appointments i.e. treatment already started
- Eye complications which may make laser treatment difficult
- Vitreous haemorrhage
- Dense media opacity
- Eye care complications which prevent a view of the retina
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Opthalmologist
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Trained non-medical professionals (eye care practitioners (ECPs)) performing laser treatment for proliferative diabetic retinopathy (PDR), and the potential impact on service capacity |
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Otro: Trained non-medical professionals (eye care practitioners (ECPs)
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Trained non-medical professionals (eye care practitioners (ECPs)) performing laser treatment for proliferative diabetic retinopathy (PDR), and the potential impact on service capacity |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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To assess the feasibility of a full clinical trial comparing trained Eye Care Professionals with ophthalmologists in performing laser treatment in line with the established protocols
Periodo de tiempo: from enrollment to the 6 month follow up visit
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Feasibility will be assessed using pre-specified progression criteria relating to: ECP participation and training completion, participant recruitment, follow-up completion, intervention compliance and retention of clinical equipoise. We will use Red, Amber, Green criteria to determine whether a larger scale trial can be done |
from enrollment to the 6 month follow up visit
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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estimate participant recruitment and retention rates.
Periodo de tiempo: from baseline to 6 month visit
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to provide an estimate of the consent rates and retention rates by counting the number of patients screened and approached and how many consented. Of those, we will determine how many remained for the full 6 months and if patients withdrew or were lost to follow up we will determine when this occured and, where possible, why |
from baseline to 6 month visit
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assess completeness and quality of outcome data collection.
Periodo de tiempo: from baseline to 6 month visit
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to assess how well data is collected and how accurate it is by conducting a data cleasning exercise in the database to identify which data are missing and any outliers suggesting data is inaccurate |
from baseline to 6 month visit
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evaluate the feasibility of intervention delivery by trained ECPs
Periodo de tiempo: from baseline to 6 month visit
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to evalaute whether it is feasible for trained ECPs to deliver the treatment and whether patients accept them. this will include assessing (usign RAG criteria) whether ECPs agree to take part |
from baseline to 6 month visit
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assess the acceptability of the intervention and trial processes to participants and stakeholders.
Periodo de tiempo: from baseline to 6 month visit
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to assess whether patients consent and remain in the trial and whether stakeholders can adhere to the protocol |
from baseline to 6 month visit
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describe clinical outcome distributions to inform the design of a future definitive trial
Periodo de tiempo: from baseline to 6 month visit
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we will determine how will various clinical data items are collected in terms of availability and accuracy to determine whether they are suitable for a larger scale study which may use one as the basis for a sample size calculation. Data include number of laser sessions, visual acuity, central retinal thickness, sight loss/retention and various patient questionnaires |
from baseline to 6 month visit
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assess the feasibility of collecting patient-reported outcome and resource-use measures
Periodo de tiempo: from baseline to 6 month visit
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to determine whether participants complete the questionnaires provided and which questions are missed out / incorrecty completed. We will run missing data reports on the questionnaires to track patterns relating to problematic questions and identify outliers which may be incorrect data |
from baseline to 6 month visit
|
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explore the resource use and cost drivers associated with ECP-delivered and ophthalmologist-delivered care pathways.
Periodo de tiempo: from baseline to 6 month visit
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to collect data related to recourse use and other cost drivers associated with the novel treatment pathway using ECPs to determine whether there are cost savings to be made in using ECPs to deliver laser treatment |
from baseline to 6 month visit
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Otros números de identificación del estudio
- IRAS 347120
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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