UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013781 |
|---|---|
| Receipt number | 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 09:44:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
mori@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016084
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
