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.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Swansea, Spojené království
- Nábor
- Swansea Bay University Health Board: Ophthalmology Department, Singleton Hospital
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Kontakt:
- Mahmoud Mr Awad
- Telefonní číslo: +44 1792 285034
- E-mail: mahmoud.awad@wales.nhs.uk
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: Opthalmologist
|
Trained non-medical professionals (eye care practitioners (ECPs)) performing laser treatment for proliferative diabetic retinopathy (PDR), and the potential impact on service capacity |
|
Jiný: Trained non-medical professionals (eye care practitioners (ECPs)
|
Trained non-medical professionals (eye care practitioners (ECPs)) performing laser treatment for proliferative diabetic retinopathy (PDR), and the potential impact on service capacity |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
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
Časové okno: from enrollment to the 6 month follow up visit
|
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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
estimate participant recruitment and retention rates.
Časové okno: from baseline to 6 month visit
|
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
|
|
assess completeness and quality of outcome data collection.
Časové okno: from baseline to 6 month visit
|
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
Časové okno: from baseline to 6 month visit
|
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.
Časové okno: from baseline to 6 month visit
|
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
Časové okno: from baseline to 6 month visit
|
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
|
|
assess the feasibility of collecting patient-reported outcome and resource-use measures
Časové okno: 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.
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- IRAS 347120
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