UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049608 |
|---|---|
| Receipt number | R000056498 |
| Scientific Title | Association between seating with pressure mapping assessmen and pressure ulcer prevention and activities of daily living for wheelchair elderly users |
| Date of disclosure of the study information | 2022/11/25 |
| Last modified on | 2024/04/22 14:54:10 |
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Basic information
Public title
Association between seating with pressure mapping assessmen and pressure ulcer prevention and activities of daily living for wheelchair elderly users
Acronym
Seating with pressure mapping assessment and the checklist for pressure ulcer and ADL
Scientific Title
Association between seating with pressure mapping assessmen and pressure ulcer prevention and activities of daily living for wheelchair elderly users
Scientific Title:Acronym
Seating with pressure mapping assessment and the checklist for pressure ulcer and ADL
Region
| Japan |
Condition
Condition
Pressure ulcer
Classification by specialty
| Rehabilitation medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether seating with pressure mapping assessment and the checklist is associated with prevention of pressure ulcer or skin problems and maintaining activities of daily living for wheelchair elderly users
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pressure mapping, seating duration, risk behaviors at wheelchair after two weeks
Key secondary outcomes
Pain, agitation, vitality, ADL, respiration, dietary intake, nutritional status, incidence of skin disorders including pressure ulcer
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients staying over one month at hospital or long-term care institution
2)Patients at risk of pressure ulcer
2-1)who have two or more scores by the risk checklist
2-2)who have pressure ulcer
2-3)who require assisstance with meals
Key exclusion criteria
1)Patients requiring palliative care
2)Patients who receive surgical treatment under general anesthesia
3)Patients using wheelchair over one hour per day
4)Patients who have indwelling catheter in the urinary tract
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Hideko |
| Middle name | |
| Last name | Tanaka |
Organization
Shonan University of Medical Sciences
Division name
Department of Nursing
Zip code
224-0806
Address
16-48 Kamishinano, Totsuka-ku, Yokohama-shi, Kanagawa-ken
TEL
045-821-0111
iizaka.tky@gmail.com
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Iizaka |
Organization
Shukutoku University
Division name
School of Nutrition, College of Nursing and Nutrition
Zip code
260-8703
Address
673 Nitonacho, Chuo-ku, Chiba-shi
TEL
043-305-1888
Homepage URL
iizaka.tky@gmail.com
Sponsor or person
Institute
Shukutoku University
Institute
Department
Personal name
Funding Source
Organization
Sumitomo Riko Company Limited, Health and Nursing Care Products Buisiness Unit
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
College of Nursing and Nutrition, Shukutoku University
Address
673 Nitonacho, Chuo-ku, Chiba-shi
Tel
043-305-1888
iizaka-tky@umin.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
| 2022 | Year | 11 | Month | 25 | 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
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
| 2022 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective cohort study. The exposed group is defined as patients receiving seating care with pressure mapping assessment and the checklist. Control group is defined as patients who receiving seating care without pressure mapping. Control group is matched with age and sex. Follow-up period is two weeks.
Management information
Registered date
| 2022 | Year | 11 | Month | 25 | Day |
Last modified on
| 2024 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056498
