UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048288 |
|---|---|
| Receipt number | R000054933 |
| Scientific Title | Effectiveness of nursing practice using humanitude to patients with dementia who have been urgently hospitalised due to femoral cervical and tumble fractures |
| Date of disclosure of the study information | 2023/03/01 |
| Last modified on | 2022/07/05 17:04:55 |
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Basic information
Public title
Effectiveness of nursing practice using humanitude to patients with dementia who have been urgently hospitalised due to femoral cervical and tumble fractures
Acronym
Effectiveness of nursing practice using humanitude to patients with dementia who have been urgently hospitalised due to femoral cervical and tumble fractures
Scientific Title
Effectiveness of nursing practice using humanitude to patients with dementia who have been urgently hospitalised due to femoral cervical and tumble fractures
Scientific Title:Acronym
Effectiveness of nursing practice using humanitude to patients with dementia who have been urgently hospitalised due to femoral cervical and tumble fractures
Region
| Japan |
Condition
Condition
Femoral cervical fracture, femoral terior fract
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Femoral cervical fractures in acute hospitalisation reveals the effectiveness of humanity of humanity for elderly people with dementia with terioral fractures, from the aspect of ADL expansion
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy of the Umanitude, ADL evaluation items
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
Nursing practises using humanitude
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
cervical fractures, femoral terior fractures
Emergency hospitalisation and surgery
ADL before the injury was walking independent
MMSE22-26 mild cognitive impairment
Key exclusion criteria
ADL before injury, wheelchair, bedridden patient
MMSE22 or 27 or higher
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | MEGUMI |
| Middle name | |
| Last name | KUBO |
Organization
Fukuoka University Chikushi Hospital
Division name
7th Floor West Ward
Zip code
818-0067
Address
1-1-1 Zokumyouin,ChikusinoCity,Fukuoka Prefecture
TEL
092-921-1011
megumi8140@adm.fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Kiyama |
Organization
Fukuoka University Chikushi Hospital
Division name
7th Floor West Ward
Zip code
818-0067
Address
1-1-1 Zokumyouin,ChikusinoCity,Fukuoka Prefecture
TEL
092-921-1011
Homepage URL
notcat2brothers@adm.fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Chikushi Hospital 7th Floor West Ward
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University Chikushi Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Biomedical Ethics,Faculty of Medicine,Fukuoka University School of Medicine
Address
7-45-1Nanakuma,Jonan-ku,Fukuoka City,Fukuoka Prefecture
Tel
092-871-6631
fumed-ethics@fukuoka-u.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 | 03 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 05 | Day |
Last modified on
| 2022 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054933
