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利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000031401
受付番号 R000033736
科学的試験名
一般公開日(本登録希望日) 2019/04/10
最終更新日 2019/12/08

※ 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
Awareness Development and Usage of mHealth Technology among Hypertensive Patients in a Rural Community of Bangladesh
一般向け試験名略称/Acronym
Increase awareness & Health Literacy, Reduce Hypertension
科学的試験名/Scientific Title
Awareness Development using of mHealth Technology among Hypertensive Patients in Bangladesh
科学的試験名略称/Scientific Title:Acronym
Awareness, mHealth, Hypertension
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
Hypertensive people
疾患区分1/Classification by specialty
該当せず/Not applicable 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
To develop awareness and enhance knowledge, which will be measured by actual behavioral changes, by using health education and mHealth technology among hypertensive patients in a rural communityof Bangladesh.

目的2/Basic objectives2 その他/Others
目的2 -その他詳細/Basic objectives -Others
2. To evaluate the level of blood pressure changes
3. To measure health status by Euro-5D-5L QOL questionnaire (Mobility, self-care, usual activities, pain/discomfort, anxiety/depression)
4. To decrease dietary salt intake (Measured by food and urinary salinity test)
5. To measure blood glucose level (Random Blood Sugar), urinary protein and glucose test to measure complications.
6. To evaluate feasibility of this intervention strategies and mHealth technology.
試験の性質1/Trial characteristics_1 その他/Others
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase

評価/Assessment
主要アウトカム評価項目/Primary outcomes
Behavioral changes by health education (evaluated by the researcher who developed questionnaire).
副次アウトカム評価項目/Key secondary outcomes
1. To decrease level of blood pressure
2. To measure health status by Euro-5D-5L QOL questionnaire
3. To decrease dietary salt intake
4. To measure blood glucose level , Urinary Protein and glucose test
5. Check the feasibility of mobile phone in hypertensive individuals

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 オープン/Open -no one is 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 動的割付けの際に施設を調整因子としている/Institution is considered as adjustment factor in dynamic allocation.
ブロック化/Blocking いいえ/NO
割付コードを知る方法/Concealment 知る必要がない/No need to know

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
行動・習慣/Behavior,custom
介入1/Interventions/Control_1
Intervention:
For 5 months follow up with mobile health text messaging (SMS), first follow up 3 SMS per week for first month and 1 SMS per week for 4 months consecutively, face to face health education and also send text message (in bangla) from the day of enrollment to till follow up period. The SMS will provide simple health education and BP measurement reminders to encourage adherence to medical advice. Research team members will send a text message to a wired person having registered cell phone number throughout the study period.
Control:
12 months, 5 months follow up without mobile health text messaging (SMS).
介入2/Interventions/Control_2
Intervention:
For 5 months follow up with mobile health text messaging (SMS), first follow up 3 SMS per week for first month and 1 SMS per week for 4 months consecutively, face to face health education and also send text message (in bangla) from the day of enrollment to till follow up period. The SMS will provide simple health education and BP measurement reminders to encourage adherence to medical advice. Research team members will send a text message to a wired person having registered cell phone number throughout the study period.
Control:
12 months, 5 months follow up without mobile health text messaging (SMS).
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
35 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
36 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
Hypertensive individuals of either sex aged 35 years or older,1-5 years of schooling, Willing to participate in the study and who consents to receive and read periodic text messages for the entire study
除外基準/Key exclusion criteria
Individuals who did not meet the inclusion criteria.

目標参加者数/Target sample size 420

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

ミドルネーム

Most Yasmin
ミドルネーム
Jahan
所属組織/Organization
Hiroshima University
所属部署/Division name
Graduate School of Biomedical and Health Sciences
郵便番号/Zip code 7348553
住所/Address
Minamiku 1-2-3, Kasumi-cho, Hiroshima, Japan
電話/TEL 082-257-5365
Email/Email d160207@hiroshima-u.ac.jp

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

Most Yasmin
ミドルネーム
Jahan
組織名/Organization
Hiroshima University
部署名/Division name
Graduate School of Biomedical and Health Sciences
郵便番号/Zip code 7348553
住所/Address
Minamiku 1-2-3, Kasumi-cho, Hiroshima, Japan
電話/TEL 082-257-5365
試験のホームページURL/Homepage URL
Email/Email d160207@hiroshima-u.ac.jp

実施責任組織/Sponsor
機関名/Institute その他 Institute of of Biomedical and Health Sciences, Hiroshima University, Japan
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 KAKENHI, Research advanced using Grants-in-Aid for Scientific Research.
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 日本の官庁/Japanese Governmental office
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
Bangladesh Medical Research Council
住所/Address
Mohakhali, Dhaka 1212, Bangladesh
電話/Tel +88-02-984-8396
Email/Email info@bmrcbd.org

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 Kumudini Women's Medical College and 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
2019 04 10

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 420
主な結果/Results
420 participants (209 in intervention and another 211 in control arm).
主な結果入力日/Results date posted
2019 05 16
結果掲載遅延/Results Delayed
遅れる予定/Delay expected
結果遅延理由/Results Delay Reason
Follow up has been completed on 23rd March 2019.
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
Normal/good
有害事象/Adverse events
Not applicable
評価項目/Outcome measures
Primary:
1. Behavioral changes by health education 
Secondary:
1. To decrease level of blood pressure 
2. To measure health status by Euro-5D-5L QOL questionnaire (Mobility, self-care, usual activities, pain/discomfort, anxiety/depression)
3. To decrease dietary salt intake (Measured by food and urinary salinity test)
4. To measure blood glucose level (Random Blood Sugar), Urinary Protein and glucose test (In order to measure the complications)
5. Check the feasibility of mobile phone in hypertensive individuals by field testing questionnaires which will be developed by the researchers
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 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2017 09 17
倫理委員会による承認日/Date of IRB
2017 09 17
登録・組入れ開始(予定)日/Anticipated trial start date
2018 08 12
フォロー終了(予定)日/Last follow-up date
2019 06 18
入力終了(予定)日/Date of closure to data entry
2019 08 31
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

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 02 21
最終更新日/Last modified on
2019 12 08


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=R000033736
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033736

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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