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利用者名:
UMIN ID:

試験進捗状況 限定募集中/Enrolling by invitation
UMIN試験ID UMIN000013567
受付番号 R000015851
科学的試験名
一般公開日(本登録希望日) 2014/04/04
最終更新日 2014/03/30

※ 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
The role of a group neuropsychological rehabilitation program in the cognitive and non-cognitive functioning of institutionalized elders
一般向け試験名略称/Acronym
Group neuropsychological rehabilitation program in institutionalized elders
科学的試験名/Scientific Title
The role of a group neuropsychological rehabilitation program in the cognitive and non-cognitive functioning of institutionalized elders
科学的試験名略称/Scientific Title:Acronym
Group neuropsychological rehabilitation program in institutionalized elders
試験実施地域/Region
欧州/Europe

対象疾患/Condition
対象疾患名/Condition
institutionalized elders without cognitive impairment, but at risk of developing so (N/D-r)
institutionalized elders with cognitive impairment no-dementia (CIND)
institutionalized elders with dementia (DE)
疾患区分1/Classification by specialty
老年内科学/Geriatrics 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
This study is aimed at evaluating whether a structured group neuropsychological rehabilitation program is critical to improving cognitive, emotional and functional outcomes in N/D-r, CIND, and DE, compared with institutionalized elders on a waiting list.
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 検証的/Confirmatory
試験の性質2/Trial characteristics_2 実務的/Pragmatic
試験のフェーズ/Developmental phase 第Ⅱ相/Phase II

評価/Assessment
主要アウトカム評価項目/Primary outcomes
Montreal Cognitive Assessment (MoCA)
Frontal Assessment Battery (FAB)
Geriatric Depression Scale (GDS)
Geriatric Anxiety Scale (GAI)
Positive Affect and Negative Affect Scale (PANAS)
Satisfaction With Life Scale (SWLS)
UCLA-Loneliness Scale (UCLA-LS)
副次アウトカム評価項目/Key secondary outcomes
Geriatric Functionality Scale (GFS)

基本事項/Base
試験の種類/Study type

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 集団/Cluster
ブラインド化/Blinding オープンだが測定者がブラインド化されている/Open -but assessor(s) 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 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 治療・ケア/Treatment
介入の種類/Type of intervention
行動・習慣/Behavior,custom
介入1/Interventions/Control_1
Seventy-two elders will be divided into three diagnostic classifications: 1) with N/D-r (n=24); 2) with CIND (n=24) and 3) with DE (n=24).
Afterwards, the elders with N/D-r will be randomly assigned to the two rehabilitation groups (experimental) (n=12; 6+6) and two waiting list groups (control) (n=12; 6+6); elders with CIND will also be randomly distributed into two rehabilitation groups (experimental) (n=12; 6+6) and two waiting list groups (control) (n=12; 6+6); the same with DE elders.
Each elder subgroup (n=6) will take part in 10 sessions and will be evaluated cognitively (in the neuropsychological area) and non-cognitively (in the emotional/psychological and functional areas) at base-line and at the end of the ten sessions (10 weeks).
The neuropsychological rehabilitation program is distributed in ten 90-min. sessions, each one including five exercises from the following domains:
- Enabler exercise orientated to reminiscence (1-10 sessions in which each participant will answer individually to several past events questions, promoting group interaction),
- Attention (1-10 sessions including visual selective attention & verbal tasks),
- Expressive Language (1, 3-5, 8-10 sessions including object naming, phonological and semantic fluency, and verbal comprehension tasks),
- Constructive praxis (2, 5, 7, 9 sessions including reproduction of relatively complex bi-dimensional pictures),
- Immediate Memory (2, 6, 7, 9 sessions including memory tasks),
- Executive functioning (8-10 sessions including inhibition programming, control, and verbal fluency tasks),
- Expressive Language orientated to reality (1-10 sessions including stimulating verbal memory tasks oriented to reality that will promote comprehension of sentences and verbal expression).
介入2/Interventions/Control_2
On the waiting list, another 72 seniors, will be assessed twice with an interval of 10 weeks.
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

適用なし/Not applicable
年齢(上限)/Age-upper limit
60 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
Institutionalized elders N/D-r, with CIND, and with DE,
all with expressive-comprehensive communication capacities, able to see and hear well enough to participate.
除外基準/Key exclusion criteria
Mental illness (e.g., major depression, psychosis), physical illness (e.g., CVA, brain tumor), or sensory illness (e.g., blindness, deafness) that may compromise their involvement in the tasks; use of medication that affects CNS (except cholinesterase inhibitor and/or SSRI).
目標参加者数/Target sample size 144

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
Helena Espirito Santo
所属組織/Organization
Instituto Superior Miguel Torga
所属部署/Division name
Psychology
郵便番号/Zip code
住所/Address
Largo da Cruz de Celas, 1, 3000-132, Coimbra, Portugal
電話/TEL +351-966926933
Email/Email helenum@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
Helena Espirito Santo
組織名/Organization
Instituto Superior Miguel Torga
部署名/Division name
Psychology
郵便番号/Zip code
住所/Address
Largo da Cruz de Celas, 1, 3000-132, Coimbra, Portugal
電話/TEL +351-966926933
試験のホームページURL/Homepage URL http://helenum.ismt.pt/My_page/Wellcome.html
Email/Email helenum@gmail.com

実施責任組織/Sponsor
機関名/Institute その他 Helena Espirito Santo
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 Centro de Estudos da Populacao, Economia e Sociedade
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 財団/Non profit foundation
研究費拠出国/Nationality of Funding Organization
Portugal

その他の関連組織/Other related organizations
共同実施組織/Co-sponsor
Instituto Superior Miguel Torga
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 Many elderly institutions from Coimbra district

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
2014 04 04

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 中間解析等の途中公開/Partially published

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
After the group neuropsychological rehabilitation program, rehabilitated group improved significantly on cognitive (t = 3.5***), executive function (t = 4.1***), and depressive symptoms (t = 1.5 n.s).
The comparison group worsened on cognitive (t = 2.6*), and executive function (t = 2,3*), and depressive symptoms increased (t = 2.5*).
There was a significant effect on MMSE, FAB, and GDS scores, after excluding pre-rehabilitation scores as a covariates [F (1, 81) = 43.98, p <0.001; eta-squared = 0.35; F (1, 80) = 28.37, p <0.001; eta-squared = 0.26; F (1, 79) = 19.66, p <0.001; eta-squared = 0.20].
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 限定募集中/Enrolling by invitation
プロトコル確定日/Date of protocol fixation
2012 02 15
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
2012 04 15
フォロー終了(予定)日/Last follow-up date
2013 11 20
入力終了(予定)日/Date of closure to data entry
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
2014 03 30
最終更新日/Last modified on
2014 03 30


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=R000015851
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015851

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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