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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031229
Receipt No. R000034908
Scientific Title Development of cognitive rehabilitation program for elder people with alcohol use disorder
Date of disclosure of the study information 2018/02/09
Last modified on 2019/08/17

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Basic information
Public title Development of cognitive rehabilitation program for elder people with alcohol use disorder
Acronym Cognitive Rehabilitation for the elderly with AUD
Scientific Title Development of cognitive rehabilitation program for elder people with alcohol use disorder
Scientific Title:Acronym Cognitive Rehabilitation for the elderly with AUD
Region
Japan

Condition
Condition Alcohol Use Disorder
Alcohol related cognitive disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness of the cognitive rehabilitation program for elder people with alcohol use disorder.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes A Japanese version of the Frontal Assessment Battery.
(assessment timing is pre and post to the intervention.)
Key secondary outcomes MMSE
Zoo Map test(From Japanese version of BADS)
TMTA
Japanese version of the FRSBE
Goal orientations & a sense of fulfillment scale(From Japanese experiential time perspective scale).
Visual analogue scale concerning alcohol problem.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention group:
Participants will receive treatment as usual(Alcohol rehabilitation program: ARP). In addition to the usual treatment, participant who are allocated in this group take part in the cognitive rehabilitation program composed by "Planning task" and "Self instruction training".CR is conducted for five weeks,1
hour session twice a week.
Interventions/Control_2 Control group:
Participants will receive treatment as usual(Alcohol rehabilitation program: ARP)only.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
65 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1. Main disease name is Alcohol Use Disorder.
2. being inpatient in special hospital of addiction.
3. MMSE score from 18 to 28
4. 2 weeks passed from the date of hospital admission.
5. having ability to make informed consent.
Key exclusion criteria 1. Primary reasons of a cognitive impairment are Alzheimer's disease, Dementia of Lewy bodies, Parkinson's disease with dementia, Frontotemporal dementia, Vascular dementia. And those who are diagnosed clearly before entering the research.

2. Taking part in intervention is inappropriate judged by the doctor in charge.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Nobuaki
Middle name
Last name Morita
Organization University of Tsukuba
Division name Faculty of Medicine
Zip code 305-8577
Address 743, Laboratory of Advanced ResearchD,1-1-1,Tennoudai,Tsukuba,Ibaraki,Japan
TEL 029-853-3099
Email nobuakim@nifty.com

Public contact
Name of contact person
1st name Chie
Middle name
Last name Nitta
Organization University of Tsukuba
Division name Graduate School of Comprehensive Human Sciences
Zip code 305-8577
Address 743, Laboratory of Advanced ResearchD,1-1-1,Tennoudai,Tsukuba,Ibaraki,Japan
TEL 029-853-3099
Homepage URL
Email sevenseas00lp1049@yahoo.co.jp

Sponsor
Institute Faculty of Medicine, University of Tsukuba
Institute
Department

Funding Source
Organization 1.NPO CABS(Incorporated nonprofit organization
,Council for Addiction Behavior Studies)

2.JSPS KAKENHI Grant
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor National Hospital Organization Kurihama Medical and Addiction center
Name of secondary funder(s)

IRB Contact (For public release)
Organization Fauculty of Medicine, University of Tsukuba
Address 1-1-1,Tennoudai,Tsukuba,Ibaraki,Japan
Tel none
Email none

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 久里浜医療センター(神奈川県)

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 09 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Sample size were N=30 on December, 2018.
Intervention group;n=13, control group ;n=13, drop-out;n=4. 
As a result of interim analysis, the scores of MMSE and FAB  were  significantly more improved in the intervention group than control group.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 01 Month 31 Day
Date of IRB
2017 Year 11 Month 24 Day
Anticipated trial start date
2018 Year 02 Month 09 Day
Last follow-up date
2019 Year 01 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 09 Day
Last modified on
2019 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034908

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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