UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051215 |
|---|---|
| Receipt number | R000058402 |
| Scientific Title | Development of a nursing care program that promotes oral intake for post-stroke patients |
| Date of disclosure of the study information | 2023/06/02 |
| Last modified on | 2024/11/29 14:58:43 |
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Basic information
Public title
Development of a nursing care program that promotes oral intake for post-stroke patients
Acronym
Development of a nursing care program that promotes oral intake for post-stroke patients
Scientific Title
Development of a nursing care program that promotes oral intake for post-stroke patients
Scientific Title:Acronym
Development of a nursing care program that promotes oral intake for post-stroke patients
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop a nursing care program that promotes oral intake for post-stroke patients to recover oral functions so that they do not deteriorate from the state immediately after stroke onset.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FOIS(Functional Oral Intake Scale)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The intervention group will implement a nursing program to promote oral intake.
The intervention period is 14 to 21 days from onset.
Interventions/Control_2
The control group will provide current nursing care based on the hospital's standard nursing plan.
The intervention period is 14 to 21 days from onset.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with cerebral infarction or cerebral hemorrhage
2. Any age
3. Not on oral intake at the time of study entry
4. Respiratory and circulatory status stable
5. Level of consciousness: JCS I-II group
6. Physician's permission to participate in the study
Key exclusion criteria
1. Is on a ventilator
2. Has a serious complication
3. Diagnosed with dementia prior to hospitalization
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | Daimon |
Organization
University of Hyogo Graduate School
Division name
Graduate School of Nursing Science
Zip code
673-8588
Address
13-71 Kita Oji-cho, Akashi-shi, Hyogo, Japan
TEL
078-925-9404
cm21g001@guh.u-hyogo.ac.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Daimon |
Organization
University of Hyogo Graduate School
Division name
Graduate School of Nursing Science
Zip code
673-8588
Address
13-71 Kita Oji-cho, Akashi-shi, Hyogo, Japan
TEL
078-925-9404
Homepage URL
cm21g001@guh.u-hyogo.ac.jp
Sponsor or person
Institute
University of Hyogo
Institute
Department
Personal name
Funding Source
Organization
YAMAJI FUMIKO NURSING RESERCH FUND
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board College of Nursing Art and Science, University of Hyogo Research Institute of Nursing Care for People and Community
Address
13-71 Kita Oji-cho, Akashi-shi, Hyogo, Japan
Tel
078-925-0860
emi_mukai@ofc.u-hyogo.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 02 | 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
| 2022 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 22 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 31 | Day |
Last modified on
| 2024 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058402
