UMIN-CTR Clinical Trial

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
Email	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
Email	notcat2brothers@adm.fukuoka-u.ac.jp

Sponsor
Institute	Fukuoka University Chikushi Hospital 7th Floor West Ward
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054933