UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000013781
Receipt No. R000016084
Scientific Title Verification of the Nursing Intervention Program to Executive Dysfunction of the Elderly
Date of disclosure of the study information 2014/04/22
Last modified on 2019/11/06 (Ver. 5)

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Basic information
Public title Verification of the Nursing Intervention Program to Executive Dysfunction of the Elderly
Acronym The Nursing Intervention Program to Executive Dysfunction
Scientific Title Verification of the Nursing Intervention Program to Executive Dysfunction of the Elderly
Scientific Title:Acronym The Nursing Intervention Program to Executive Dysfunction
Region
Japan

Condition
Condition Dementia
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verification of the Nursing Intervention Program to Executive
Dysfunction of the Elderly
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Behavioural Assessment of the Dysexecutive Syndrome
Key secondary outcomes Instrumental activities of daily living

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 To enhance executive function, the program
is structured by six steps(Planning , goal setting, step-by-step instructions, check the procedure, practice and evaluation)
Interventions/Control_2
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
55 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Person with dementia.
Person agree to this study.
MMSE is 21 points or more.
Key exclusion criteria MMSE is 20 points or less.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Chizuru
Middle name
Last name MORI
Organization University of Tsukuba
Division name Faculty of Medicine
Zip code 305-8577
Address 1-1-1,Tennodai,Tsukuba,City ,Ibaraki
TEL 029-853-8062
Email mori@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name Chizuru
Middle name
Last name MORI
Organization University of Tsukuba
Division name Faculty of Medicine
Zip code 305-8577
Address 1-1-1,Tennodai,Tsukuba,City ,Ibaraki
TEL 029-853-8062
Homepage URL http://www.md.tsukuba.ac.jp/nursing-sci/mentalhealth/index.html
Email mori@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization University of Tsukuba
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization University of Tsukuba
Address 1-1-1,Tennodai,Tsukuba,City ,Ibaraki
Tel 029-853-3022
Email sien.ningenss@un.tsukuba.ac.jp

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 筑波大学附属病院（茨城県）

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 22 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000016084
Publication of results Unpublished

Result
URL related to results and publications https://insights.ovid.com/crossref?an=00006939-201909000-00004
Number of participants that the trial has enrolled 10
Results 
The postintervention the Behavioral Assessment of Dysexecutive Syndrome total profile and 2-subtests were significantly higher than the preintervention scores. The instrumental Activities of Daily Living Scale and the Visual Analog Scale were significantly improved.
This intervention program leads to improvement in the executive function of planning ability and promotes independence and self-confidence in patients.
Results date posted
2019 Year 11 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Ten inpatients with dementia
(a Mini-Mental State Examination score > 20)
Participant flow 
This study was approved by the ethics committee. Written informed consent was obtained from the participants. To ensure that they had enough information before making this decision, the participants were informed about the possibility of opting out of the study and that their anonymity would be guaranteed during the data analysis and reporting.
Adverse events 
not in particular
Outcome measures 
Behavioral Assessment of the Dysexecutive Syndrome (BADS)
Trail Making Test (TMT)
Instrumental ADL scale
Visual Analog Scale
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 04 Month 09 Day
Date of IRB
2014 Year 04 Month 25 Day
Anticipated trial start date
2014 Year 05 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 04 Month 21 Day
Last modified on
2019 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016084