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利用者名:
UMIN ID:

試験進捗状況 開始前/Preinitiation
UMIN試験ID UMIN000034552
受付番号 R000039385
科学的試験名
一般公開日(本登録希望日) 2018/10/17
最終更新日 2018/10/17

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title
Integrating Diabetic Retinopathy Into Mainstream Health System in Bangladesh
一般向け試験名略称/Acronym
Integrating DR Into Mainstream Health System in Bangladesh
科学的試験名/Scientific Title
Integrating Diabetic Retinopathy Into Mainstream Health System in Bangladesh
科学的試験名略称/Scientific Title:Acronym
Integrating DR Into Mainstream Health System in Bangladesh
試験実施地域/Region
アジア(日本以外)/Asia(except Japan)

対象疾患/Condition
対象疾患名/Condition
Patients with Diabetes
疾患区分1/Classification by specialty
眼科学/Ophthalmology 成人/Adult
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1
The general objective is to recommend health education intervention strategies that can be used to effectively integrate Diabetic Retinopathy into mainstream diabetes management services, by addressing gaps and strengthening the existing referral system. The specific objective is to investigate the effect of a health education intervention on patients with probable Diabetic Retinopathy who did not attend eye screening appointment with an Eye Consultant following referral from a diabetes clinic.
目的2/Basic objectives2 有効性/Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1 探索的/Exploratory
試験の性質2/Trial characteristics_2 実務的/Pragmatic
試験のフェーズ/Developmental phase 第Ⅲ相/Phase III

評価/Assessment
主要アウトカム評価項目/Primary outcomes
Increase in Successful Referrals:
Increase in Successful Referrals resulting from a health education intervention (among non-compliant persons, i.e.
those who do not avail appointment with an Eye Consultant at a tertiary hospital after being detected with probable
Diabetic Retinopathy at a diabetes hospital) - to be measured using Pre and Post intervention questionnaire based on
previously used questionnaires of similar published studies
[Time Frame: 5 months
副次アウトカム評価項目/Key secondary outcomes
Increase in knowledge about Diabetic Retinopathy: Increase in knowledge about Diabetic Retinopathy (to be measured using Pre and Post intervention questionnaires based on previously used questionnaires of similar published studies; a total of 9 questions will be allotted to assess participants' knowledge on Diabetic Retinopathy. Accurate response rates regarding knowledge about Diabetic Retinopathy will be calculated by scoring responses out of 9. Participants who correctly answer atleast 7 will be considered to have good knowledge on Diabetic Retinopathy)
[Time Frame: 5 months]

基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 並行群間比較/Parallel
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 個別/Individual
ブラインド化/Blinding 試験参加者がブラインド化されている単盲検/Single blind -participants are blinded
コントロール/Control 無治療対照/No treatment
層別化/Stratification いいえ/NO
動的割付/Dynamic allocation いいえ/NO
試験実施施設の考慮/Institution consideration 施設を考慮していない/Institution is not considered as adjustment factor.
ブロック化/Blocking いいえ/NO
割付コードを知る方法/Concealment 封筒法/Numbered container method

介入/Intervention
群数/No. of arms 2
介入の目的/Purpose of intervention 教育・カウンセリング・トレーニング/Educational,Counseling,Training
介入の種類/Type of intervention
その他/Other
介入1/Interventions/Control_1
Behavioral: Health Education Intervention
Face-to-face health education intervention on Diabetic
Retinopathy and available services at a tertiary
hospital, followed by telephonic reminder at Day 7, 30
and 90.
介入2/Interventions/Control_2
No Intervention will be conducted in this control group
介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
18 歳/years-old 以上/<=
年齢(上限)/Age-upper limit

適用なし/Not applicable
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
1. Atleast 18 years of age
2. Persons with diabetes who are registered
with Barishal Diabetes Hospital and referred to SBMC&H (tertiary hospital) for DR management (screening/ treatment) from September 2017 to August 2018
3. Persons who did not undergo a Dilated Fundus Examination (DFE) in last 12 months
4. Those who provide informed consent to be included in this study
除外基準/Key exclusion criteria
1. Below 18 years of age
2. Persons with diabetes who are registered with Barishal Diabetes Hospital
but not referred to SBMC&H (tertiary hospital) for DR management
3. Persons with diabetes referred to SBMC&H before September 2017 or
after August 2018
4. Persons who have undergone a Dilated Fundus Examination (DFE) in last
12 months
5. Those who do not provide informed consent to be included in this study
目標参加者数/Target sample size 180

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム


ミドルネーム
Zara Khair
所属組織/Organization
Hiroshima University
所属部署/Division name
Graduate School of Biomedical & Health Sciences
郵便番号/Zip code
住所/Address
Flat B1, A/80, Road-2, Niketan, Gulshan-1, Dhaka 1212, Bangladesh
電話/TEL +8801715342168
Email/Email zara.oikee@gmail.com

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム


ミドルネーム
Zara Khair
組織名/Organization
Hiroshima University
部署名/Division name
Graduate School of Biomedical & Health Sciences
郵便番号/Zip code
住所/Address
Flat B1, A/80, Road-2, Niketan, Gulshan-1, Dhaka 1212, Bangladesh
電話/TEL +8801715342168
試験のホームページURL/Homepage URL
Email/Email zara.oikee@gmail.com

実施責任組織/Sponsor
機関名/Institute その他 Self-sponsored
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 None (Self-sponsored)
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 自己調達/Self funding
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization

住所/Address

電話/Tel
Email/Email

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions Sher-e-Bangla Medical College & Hospital; Barishal Diabetes Hospital

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2018 10 17

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled
主な結果/Results

主な結果入力日/Results date posted
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 開始前/Preinitiation
プロトコル確定日/Date of protocol fixation
2018 10 16
倫理委員会による承認日/Date of IRB
登録・組入れ開始(予定)日/Anticipated trial start date
2018 11 01
フォロー終了(予定)日/Last follow-up date
2019 03 31
入力終了(予定)日/Date of closure to data entry
2019 04 30
データ固定(予定)日/Date trial data considered complete
2019 04 30
解析終了(予定)日/Date analysis concluded
2019 04 30

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2018 10 17
最終更新日/Last modified on
2018 10 17


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000039385
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039385

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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