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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 UMIN000038422
受付番号 R000043761
科学的試験名
一般公開日(本登録希望日) 2019/10/31
最終更新日 2019/10/29

※ 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
Effectiveness Cognitive Behavior Therapy (CBT) to improves adherence to fluid restriction in End Stage Renal Disease (ESRD) patients undergoing hemodialysis : Randomized Controlled Trial
一般向け試験名略称/Acronym
The use Cognitive Behavior Therapy (CBT) in End Stage Renal Disease (ESRD) patients undergoing hemodialysis
科学的試験名/Scientific Title
Effectiveness Cognitive Behavior Therapy (CBT) to improves adherence to fluid restriction in End Stage Renal Disease (ESRD) patients undergoing hemodialysis : Randomized Controlled Trial
科学的試験名略称/Scientific Title:Acronym
The use Cognitive Behavior Therapy (CBT) in End Stage Renal Disease (ESRD) patients undergoing hemodialysis
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
End Stage Renal Disease (ESRD) patients undergoing hemodialysis
疾患区分1/Classification by specialty
該当せず/Not applicable
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 study of effectiveness Cognitive Behavior Therapy (CBT) to improves adherence to fluid restriction in End Stage Renal Disease (ESRD) patients undergoing hemodialysis
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 説明的/Explanatory
試験のフェーズ/Developmental phase 該当せず/Not applicable

評価/Assessment
主要アウトカム評価項目/Primary outcomes
improves adherence to fluid restriction
副次アウトカム評価項目/Key secondary outcomes
improves self efficacy, quality of life and decrease anxiety and depression level

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 はい/YES
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 中央登録/Central registration

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
Cognitive Behavioral Therapy for 6 weeks and every therapy session last for 60 minutes.
介入2/Interventions/Control_2
Patient's in control group received no therapy at all.
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
90 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
Individual diagnosed with ESRD by a nephrologist, have non-adherence problem to diet restriction (recommended from nephrologist and nurse; when patients are unable to reach dry weight at the very least in the last five HD sessions, aged more than 18 years, undergoing hemodialysis for more than 6 months, and have an adequate command of the Indonesian language.
除外基準/Key exclusion criteria
Patients who had a mental illness, disabilities, speech-hearing problems, and memory loss were excluded
目標参加者数/Target sample size 30

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

ミドルネーム

Kustimah
ミドルネーム
Kustimah
所属組織/Organization
Faculty of Psychology, Universitas Padjadjaran
所属部署/Division name
Department of Clinical Psychology
郵便番号/Zip code 45363
住所/Address
Jl. Raya Bandung-Sumedang Km.21 Jatinangor- Sumedang- Jawa Barat- Indonesia
電話/TEL +62227794126
Email/Email kustimah@unpad.ac.id

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

Kustimah
ミドルネーム
Kustimah
組織名/Organization
Faculty of Psychology, Universitas Padjadjaran
部署名/Division name
Department of Clinical Psychology
郵便番号/Zip code 45363
住所/Address
Jl. Raya Bandung-Sumedang Km.21 Jatinangor- Sumedang- Jawa Barat- Indonesia
電話/TEL +62227794126
試験のホームページURL/Homepage URL http://psikologi.unpad.ac.id/
Email/Email humas.psikologi@unpad.ac.id

実施責任組織/Sponsor
機関名/Institute その他 Faculty of Psychology - Universitas Padjadjaran Bandung, West Java - Indonesia

Department of Clinical Psychology
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 Indonesian Endowment Fund for Education/ Lembaga Pengelola Dana Pendidikan (LPDP)
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 その他の国の官庁/Government offices of other countries
研究費拠出国/Nationality of Funding Organization
Indonesia

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
Komisi Etik Penelitian Universitas Padjajaran
住所/Address
Jl. Prof. Eijkman No. 38 Bandung
電話/Tel +62222038697
Email/Email etik.unpad@gmail.com

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 RS Al Islam Bandung
Jl. Soekarno-Hatta No. 644 RT. 001 RW. 001 Kel. Manjahlega Kec. Rancasari-Bandung
40286- Indonesia

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 10 31

関連情報/Related information
プロトコル掲載URL/URL releasing protocol https://benthamopen.com/FULLTEXT/TOPSYJ-12-141
試験結果の公開状況/Publication of results 最終結果が公表されている/Published

結果/Result
結果掲載URL/URL related to results and publications https://benthamopen.com/FULLTEXT/TOPSYJ-12-141
組み入れ参加者数/Number of participants that the trial has enrolled 31
主な結果/Results
CBT enhance adherence to fluid restriction, self-efficacy and QoL and decreasing level of anxiety and depression in End Stage Renal Disease patients undergoing Hemodialysis
主な結果入力日/Results date posted
2019 10 28
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
Adult ESRD patients who have non-adherence problem to diet restriction, undergoing hemodialysis for more than 6 months and have an adequate command of the Indonesian language. 
参加者の流れ/Participant flow
First, we assessed the total ESRD patients who eligible for this study (n=230). There were 184 patients excluded from the current study because (1) did not meet inclusion criteria (n=150), (2) declined the opportunity to participate (n=11) and (3) unable to participate (n=23). Forty-six of the original participants blinded to intervention randomization (unaware if they had been randomized to CBT or control group). Both intervention and control group have 23 participants. In intervention group, nine participants dropped out because of deceased (n=5), ill health (n=3) and refused to continue the therapy (n=1). While in control group, six participants dropped out because deceased (n=2) and ill health (n=4). Finally, the intervention and control group comprised of 14 and 17 participants, respectively. 
有害事象/Adverse events
However, participants may experience tiredness after the therapy both physically and psychologically. Some of the information presented or asked by the therapist may be distressing or uncomfortable, in which case additional support may be arranged. Information will be kept confidential and each participant will be anonymous.  
評価項目/Outcome measures
IDWG, anxiety, depression, self-efficacy and quality of life. 
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 07 10
倫理委員会による承認日/Date of IRB
2018 01 04
登録・組入れ開始(予定)日/Anticipated trial start date
2018 03 01
フォロー終了(予定)日/Last follow-up date
2018 05 01
入力終了(予定)日/Date of closure to data entry
2018 05 30
データ固定(予定)日/Date trial data considered complete
2018 06 05
解析終了(予定)日/Date analysis concluded
2018 08 05

その他/Other
その他関連情報/Other related information
The data support the improvement of self-efficacy and QoL and decreasing level of anxiety and depression in End Stage Renal Disease patients undergoing Hemodialysis

管理情報/Management information
登録日時/Registered date
2019 10 29
最終更新日/Last modified on
2019 10 29


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=R000043761
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043761

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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