UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048904 |
|---|---|
| Receipt number | R000055723 |
| Scientific Title | Pressure injury prevention App for Care manager's knowledge and behavior changing at home care: A pre-post study |
| Date of disclosure of the study information | 2022/09/11 |
| Last modified on | 2025/02/10 12:14:18 |
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Basic information
Public title
Does the use of pressure injury prevention Apps provide care manager's knowledge and behavior changing?
Acronym
Does the use of pressure injury prevention Apps provide care manager's knowledge and behavior changing?
Scientific Title
Pressure injury prevention App for Care manager's knowledge and behavior changing at home care: A pre-post study
Scientific Title:Acronym
Does the use of pressure injury prevention Apps provide care manager's knowledge and behavior changing?
Region
| Japan |
Condition
Condition
Pressure injury
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of the use of pressure injury prevention App on care managers' knowledge and behavior changing
Basic objectives2
Others
Basic objectives -Others
Knowledge and behavior changing
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Care managers knowledge of pressure injury prevention, after pressure injury prevention App is used for 6 months
Key secondary outcomes
Care managers behavior changing of pressure injury prevention, after pressure injury prevention App is used for 6 months
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
To use pressure injury prevention apps in daily practice
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Care managers who participate the "Kita-ku Care Managers' Association" implemented in Kita-ku, Tokyo
Key exclusion criteria
1. Care managers with no caseload at the time the study was conducted
2. Participants who are deemed inappropriate to participate this study by the principal or study investigators.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masushi |
| Middle name | |
| Last name | Kohta |
Organization
Fujita Health University
Division name
Research Center for Implementation Nursing Science Initiative
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-machi, Toyoake, Aichi
TEL
0562-93-2000
masushi.kota@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Masushi |
| Middle name | |
| Last name | Kohta |
Organization
Fujita Health University
Division name
Research Center for Implementation Nursing Science Initiative
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-machi, Toyoake, Aichi
TEL
0562-93-2000
Homepage URL
masushi.kota@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita health university
Institute
Department
Personal name
Funding Source
Organization
ALCARE Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Akabane Central General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-machi, Toyoake, Aichi
Tel
0562-93-2000
f-irb@fujita-hu.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
北区ケアマネジャーの会（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 11 | Day |
Related information
URL releasing protocol
https://formative.jmir.org/2025/1/e57768
Publication of results
Published
Result
URL related to results and publications
https://formative.jmir.org/2025/1/e57768
Number of participants that the trial has enrolled
27
Results
The total mean knowledge score significantly increased from 30.9 (SD 5.9) in the pretest group to 36.1 (SD 5.9) in the posttest group (P=.0003).
For the level of practice, the total score increased from 15.2 (SD 3.1) in the pretest group to 16.2 (SD 3.0) in the posttest group, but no statistically significant differences were observed (P=.16).
Results date posted
| 2025 | Year | 02 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Most participants were in their 40 and 50 seconds, and 12 out of 19 participants (63%) were female.
All of the participants had a background in social welfare; that is, participants who studied medicine or nursing were not included in this study.
Participant flow
The accessible population included individuals with a care manager license and those who participated in the Kita-ku Care Managers Association in Kita-ku, Tokyo.
In a meeting hold by the association, the researchers orally explained the details of this study.
A total of 27 individuals agreed to participate, and the pretest was completed. App (named Pips-Map) was downloaded and operated for 6 months in daily practice.
Adverse events
No adverse events to be reported.
Outcome measures
1) Self-administered test questionnaire to measure knowledge level for the pressure injury prevention.
2) Self-administered test questionnaire to measure actual practice level for the pressure injury prevention.
3) Behavior change potential by the use of app.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 10 | Day |
Last modified on
| 2025 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055723
