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Name:
UMIN ID:

Recruitment status Main results already published
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 2020/05/12

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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 The primary outcome was changes in foot-care knowledge (30 questions) and practice (20 questions) scores collected before and after the intervention for both groups.The second outcome was programme-related learning perceptions.


almost 2 months period
Key secondary outcomes Secondary outcomes are clients condition on foot, physical performance and psychological aspects.
foot assessment
4 meter walking speed toe force
skin temperature
floating toes



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 period: almost 2months
Session 1
PPT: Introduction of the programme,
Discuss the purpose and necessity of the study, foot-care regulation, association between national budget/social issue and foot problem, anatomy, physiology of nail, skin, toe, foot, a variety of foot-care practice.
10-minutes motion pictures: Foot-care practice including method of foot bath, cutting nail, arrange nail edge with file, removing pain for ingrown nail.
Other materials: 19-page picture story card, 78-page foot care note, one-page foot-care assessment sheet were given to each provider. Toenail file was given to each participant Daytime or nighttime
5 to 10 participants
Training

Session 2 The main researcher demonstrated participants how to assess client's feet and to use foot file or nail file or foot massage.
Foot file was given to each provider.Daytime or nighttime
1 (individual training) to 10 participants (group training)

Follow up Session 3
The researcher demonstrated participants how to assess client's feet and to use foot file or nail file or foot massage.
Foot file was given to each provider.
One-point advice card was given Day tome or nighttime
1 to 3 participants for one-day service centre or one-day care centre offering rehabilitation.
5 participants for home visiting provider

Follow up Session 4
The researcher shared foot assessment and skills with one or two available participants and asked her/him to do same thing at the time Foot models were clients with consent
Same as above
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 87

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 Partially published

Result
URL related to results and publications https://onlinelibrary.wiley.com/doi/full/10.1002/nop2.479
Number of participants that the trial has enrolled 87
Results Before adjusting for background, total scores of knowledge and practice categories were higher than the baseline in the intervention group(43 participants) compared with the control group(44 participants). After background correction due to potential bias of non-random cluster sampling, significant differences between groups were observed in mean score changes in skin and consultation subscales of the practice category.
Results date posted
2020 Year 05 Month 12 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2020 Year 04 Month 20 Day
Baseline Characteristics The analysis was 43 for 11 providers in the intervention group and 44 for 10 providers in the control group. Mean ages were 47 (SD = 11.8) and 50 (SD = 11.6) years in the intervention and control groups, respectively. Working experiences were 12.1 (SD = 10.2) and 14.8 (SD = 11.6) years, respectively.
Participant flow Out of 43 participants, 42 were able to attend session 1 (power point presentation and motion pictures). Participation was 30.

Some providers were not able to set the time for session 2. Therefore, session 2 was replaced by session 3.
Adverse events
Outcome measures The primary outcome was knowledge and practice scores collected pre and post the intervention for both groups. Before the intervention, demographic data were obtained, including, sex, profession, working status, age, working experiences and the number of clients cared for in a day
The second outcome was programme-related learning.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2019 Year 06 Month 30 Day
Date of IRB
2019 Year 06 Month 19 Day
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
2020 Year 05 Month 12 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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