UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031229 |
|---|---|
| Receipt number | 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 07:57:20 |
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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
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
sevenseas00lp1049@yahoo.co.jp
Sponsor or person
Institute
Faculty of Medicine, University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034908
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
