UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046433 |
|---|---|
| Receipt number | R000052971 |
| Scientific Title | Development and evaluation of a training program based on the PPDAC cycle for head nurses to reduce the incidence of falls among hospitalized patients |
| Date of disclosure of the study information | 2021/12/22 |
| Last modified on | 2023/04/17 13:39:12 |
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Basic information
Public title
Development and evaluation of a training program based on the PPDAC cycle (information-based problem solving management cycle) for head nurses to reduce the incidence of falls among hospitalized patients
Acronym
Development and evaluation of a training program based on the PPDAC cycle (information-based problem solving management cycle) for head nurses to reduce the incidence of falls among hospitalized patients
Scientific Title
Development and evaluation of a training program based on the PPDAC cycle for head nurses to reduce the incidence of falls among hospitalized patients
Scientific Title:Acronym
Development and evaluation of a training program based on the PPDAC cycle for head nurses to reduce the incidence of falls among hospitalized patients
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop and evaluate a training program based on the PPDAC cycle for head nurses in order to reduce the incidence of falls among hospitalized patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of falls among hospitalized patients
Key secondary outcomes
Competencies for head nurses (scale score)
PPDAC competencies (scale score)
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
A training program based on the PPDAC cycle for head nurses to reduce the incidence of falls among hospitalized patients (twice for 6 hours each time)
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
Head nurses working in wards (including intensive care unit)
Key exclusion criteria
None
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | AKIKO |
| Middle name | |
| Last name | MORIMOTO |
Organization
Osaka Prefecture University
Division name
Department of Nursing Informatics, Graduate School of Nursing
Zip code
583-8555
Address
3-7-30 Habikino, Habikino-city, Osaka 583-8555, Japan.
TEL
072-950-2111
morimotoakiko@nursing.osakafu-u.ac
Public contact
Name of contact person
| 1st name | MIWA |
| Middle name | |
| Last name | FUKUMITSU |
Organization
Osaka Prefecture University
Division name
Department of Nursing Informatics, Graduate School of Nursing
Zip code
583-8555
Address
3-7-30 Habikino, Habikino-city, Osaka 583-8555, Japan
TEL
072-950-2111
Homepage URL
me601014@edu.osakafu-u.ac.jp
Sponsor or person
Institute
Osaka Prefecture University
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethical Research Review Board at Osaka Prefecture University Graduate School of Nursing
Address
3-7-30 Habikino, Habikino-city, Osaka 583-8555, Japan
Tel
072-950-2111
kangorinri@nursing.osakafu-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
| 2021 | Year | 12 | Month | 22 | 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
18
Results
A significant trend in the incidence of falls and falls among inpatients in the wards was found as a result of pre- and post-intervention comparisons before and 6 months after the intervention. In particular, the high falls and falls incidence group at the time of the pre-intervention survey showed a significant decrease in the falls and falls incidence rate 6 months after the intervention compared to before the intervention.
Results date posted
| 2023 | Year | 04 | Month | 17 | Day |
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
Completed
Date of protocol fixation
| 2021 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 21 | Day |
Last modified on
| 2023 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052971
