UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018228 |
|---|---|
| Receipt number | R000021099 |
| Scientific Title | Development of a care protocol that preserves cognitive function to prevent delirium in the elderly |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2016/03/03 17:25:39 |
* 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
Development of a care protocol that preserves cognitive function to prevent delirium in the elderly
Acronym
Development of a care protocol to prevent delirium
Scientific Title
Development of a care protocol that preserves cognitive function to prevent delirium in the elderly
Scientific Title:Acronym
Development of a care protocol to prevent delirium
Region
| Japan |
Condition
Condition
Elderly patients
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To clarify the changes in the delirium state according to a care protocol that preserves cognitive function to prevent delirium in elderly patients.
2. To evaluate the practicality of the care protocol.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The Japanese version of the NEECHAM Confusion Scale
Evaluation is performed twice a day during the intervention period.
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
Intervention period: November 2015 to December 2015
Intervention days: 3 days
Interventions:
1. Test cognitive function and audiovisual functions.
2. Support for audiovisual functions.
3. Activities and optimization of rest.
4. Implement reality orientation.
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.75 years old or more
2.Cognitive function is normally or mildly impaired before hospitalization.
3.Treatment is provided by the internal medicine department during the implementation period of the care protocol.
4.Routine conversation in Japanese is possible.
5.The physician determines that there are no obstacles to patient participation in this research.
6.The patient agrees to participate in this research.
Key exclusion criteria
Those who undergo surgical treatment such as operative procedures, etc., during the implementation period of the care protocol.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | SUGAWARA Mineko |
Organization
Kitasato University
Division name
School of Nursing
Zip code
Address
1-2-1,Kitasato,Minami-ku,Sagamihara,Kanagawa
TEL
042-778-9281
mchiyo79@nrs.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | SUGAWARA Mineko |
Organization
Kitasato University
Division name
School of Nursing
Zip code
Address
1-2-1,Kitasato,Minami-ku,Sagamihara,Kanagawa
TEL
042-778-9281
Homepage URL
mchiyo79@nrs.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
北里大学 北里研究所病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2015 | Year | 06 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 07 | Day |
Last modified on
| 2016 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021099
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
