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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036307
Receipt No. R000041336
Scientific Title The development of the program enhancing foot care practice for nurses and care workers at home-based services
Date of disclosure of the study information 2019/07/25
Last modified on 2019/03/27

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Basic information
Public title The development of the program enhancing foot care practice for nurses and care workers at home-based services
Acronym The foot care practice intervention for
nurses and care workers
Scientific Title The development of the program enhancing foot care practice for nurses and care workers at home-based services
Scientific Title:Acronym The foot care practice intervention for
nurses and care workers
Region
Japan

Condition
Condition nurses and care workers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To improve the quality of care for clients, the study aimed to develop the educational program enhancing practices on foot including the finding of foot problems, assessment on nail or skin etc., hygine care,and foot protection for physical care-led nurses and care workers at home-based services.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Primary outcomes will be measured by (1)
foot knowledge and practice questionnaries
for nurses and care workers at baseline and one-month after intervetion, and immediately after intervention (2) an evaluation sheet to evaluate description in foot care note at each visits by researcher.Items of evaluation sheet includes description of foot assessment,care etc.
Key secondary outcomes Secondaly outcomes are clients' condition of foot, physical performance and psychological aspects.
(1)Foot assessment (scores)
(2)Shorty Physical Performance battery test(scores)
(3)Toes force (scores)
(4)Skin water quantitiy(%)
(5)Geriatric Depresson Scale(scores)


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 Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 Intervention
1.Providing knowledge on foot via Power point presentation 10 minutes
2. DVD 10 minutes
3. Pracice training 20mim
4. Follow-up training 10 to 20 minutes to enhancing knowledge and practice in nurses and care workers(using Drawing pictures)
5. Promoting nurse and care workers to asess on client's foot and describe it in foot care note on daily levels.

Researcher visit 4 times for intervention
First visit: Education with PPT and DVD
at baseline
Second visit: Pracitice traing at one week later
Third visit: Follow up traiing at two week later
Fourth visit: Follow up traing at one month later
Interventions/Control_2 Control
They contiune only regular care
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Nurses and care workers who do physically-
related cares, such as assisting bath, changing diper and clean the body, etc.
Key exclusion criteria Nurse and care workers who are planning to quit the job during the intervention.
Care workers who assist only daily living matters, such as shopping, cleaning the house for clients.
Target sample size 240

Research contact person
Name of lead principal investigator
1st name kashiko
Middle name
Last name fujii
Organization Nagoya University Graduate School of Medicine
Division name school of health sciences
Zip code 4618673
Address 1-1-20 Daiko-minami Higashi-ku Nagoya Aichi
TEL 08052949091
Email fujii_k@met.nagoya-u.ac.jp

Public contact
Name of contact person
1st name kashiko
Middle name
Last name fujii
Organization Nagoya University Graduate School of Medicine
Division name school of health sciences
Zip code 4618673
Address 1-1-20 Daiko-minami Higashi-ku Nagoya Aichi
TEL 08052949091
Homepage URL
Email fujii_k@met.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate school of medicine
Institute
Department

Funding Source
Organization Nagoya City Medical Home Care
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 Ethcs Review committe of Nagoya University Graduate School of Medicine
Address 65 turumaicho showa-ku
Tel 0527442479
Email ethics@med.nagoya-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 名古屋市のデイサービス、デイケア、訪問看護ステーション、訪問介護ステーション

Other administrative information
Date of disclosure of the study information
2019 Year 07 Month 25 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
2019 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2019 Year 07 Month 01 Day
Last follow-up date
2019 Year 10 Month 30 Day
Date of closure to data entry
2019 Year 11 Month 30 Day
Date trial data considered complete
2019 Year 12 Month 15 Day
Date analysis concluded
2019 Year 12 Month 30 Day

Other
Other related information

Management information
Registered date
2019 Year 03 Month 27 Day
Last modified on
2019 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041336

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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