UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036307 |
|---|---|
| Receipt number | 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 18:53:20 |
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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
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
fujii_k@met.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate school of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041336
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| Registered date | File name |
| Research case data | |
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