UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057294 |
|---|---|
| Receipt number | R000064898 |
| Scientific Title | Utility of Clinical Decision Support System for Pressure Ulcer Management : A Randomized Crossover Pilot Study |
| Date of disclosure of the study information | 2025/03/15 |
| Last modified on | 2026/01/31 23:18:27 |
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Basic information
Public title
Utility of Clinical Decision Support System for Pressure Ulcer Management : A Randomized Crossover Pilot Study
Acronym
Utility of Clinical Decision Support Systems for Pressure Ulcer Management
Scientific Title
Utility of Clinical Decision Support System for Pressure Ulcer Management : A Randomized Crossover Pilot Study
Scientific Title:Acronym
Utility of Clinical Decision Support Systems for Pressure Ulcer Management
Region
| Japan |
Condition
Condition
Dermatological diseases
Plastic surgery diseases
Classification by specialty
| Dermatology | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This pilot study aims to evaluate the effectiveness and utility of clinical decision support systems (CDSS) in the management of pressure ulcers by leveraging photographic evidence of the ulcers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome was the proportion of participants who selected both correct ointment and wound dressing options.
Key secondary outcomes
The secondary outcomes were comparisons of the correct response rates for ointment and for wound dressing options.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
| Other |
Interventions/Control_1
The study employs a randomized crossover design, wherein participants are divided into two groups to ensure a balanced assessment of the intervention. Participants in Group A first undergo the intervention part, utilizing the CDSS to assist in their decision-making process for pressure ulcer treatment, followed by a control part without CDSS support. Conversely, participants in Group B begin with the control part and then proceed to the intervention part.
Interventions/Control_2
Using clinical decision support systems for pressure ulcer treatment specifically developed for this study.
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. A resident physician at Dokkyo Medical University Hospital and physicians at Department of Diagnostic and Generalist Medicine of Dokkyo Medical University
2. Individuals who have provided written informed consent after receiving a full explanation of the study
Key exclusion criteria
1. Individuals with significant vision impairment
2. Individuals deemed ineligible by the researcher to participate in this study
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Ito |
| Middle name | |
| Last name | Takahiro |
Organization
Dokkyo Medical University
Division name
Department of Diagnostic and Generalist Medicine
Zip code
321-0293
Address
880 Kitakobayashi, Mibu-cho, Shimotsuga-gun, Tochigi
TEL
0282-86-1111
i-taka@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Ito |
| Middle name | |
| Last name | Takahiro |
Organization
Dokkyo Medical University
Division name
Department of Diagnostic and Generalist Medicine
Zip code
321-0293
Address
880 Kitakobayashi, Mibu-cho, Shimotsuga-gun, Tochigi
TEL
0282-86-1111
Homepage URL
i-taka@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
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
The Ethics Committee of Dokkyo Medical University
Address
880 Kitakobayashi, Mibu-cho, Shimotsuga-gun, Tochigi
Tel
0282-86-1111
r-kenkyu@dokkyomed.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
| 2025 | Year | 03 | Month | 15 | 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
28
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
Completed
Date of protocol fixation
| 2024 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 14 | Day |
Last modified on
| 2026 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064898
