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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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-
-
Swansea、イギリス
- 募集
- Swansea Bay University Health Board: Ophthalmology Department, Singleton Hospital
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コンタクト：
- Mahmoud Mr Awad
- 電話番号：+44 1792 285034
- メール：mahmoud.awad@wales.nhs.uk
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Opthalmologist
|
Trained non-medical professionals (eye care practitioners (ECPs)) performing laser treatment for proliferative diabetic retinopathy (PDR), and the potential impact on service capacity |
|
他の：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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
estimate participant recruitment and retention rates.
時間枠：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.
時間枠：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
時間枠：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.
時間枠：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
時間枠：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
時間枠：from baseline to 6 month visit
|
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.
時間枠：from baseline to 6 month visit
|
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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- IRAS 347120
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。