UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052183 |
|---|---|
| Receipt number | R000059556 |
| Scientific Title | Testing the Effectiveness of an Oral Care Program for Bedridden Parenteral Older Adults Patients |
| Date of disclosure of the study information | 2023/09/12 |
| Last modified on | 2024/09/12 17:23:35 |
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Basic information
Public title
Effectiveness of Oral Care with Gel Moisturizers for Older Adults requiring Nursing Care with Swallowing Problems
Acronym
Effectiveness of Oral Care with Gel Moisturizers for Older Adults requiring Nursing Care with Swallowing Problems
Scientific Title
Testing the Effectiveness of an Oral Care Program for Bedridden Parenteral Older Adults Patients
Scientific Title:Acronym
Effectiveness of Oral Care with Gel Moisturizers for Older Adults requiring Nursing Care with Swallowing Problems
Region
| Japan |
Condition
Condition
dysphagia
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of this oral care provided by nurses in terms of changes in oral status, oral moisture, and oral bacterial counts.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral bacterial counts at 1 day, 3 days, and 1, 2, 4, 6, and 8 weeks after the start of care
Key secondary outcomes
Oral condition, and oral moistnes at 1 day, 3 days, and 1, 2, 4, 6, and 8 weeks after the start of care
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
nurse-administered oral care using a gel moisturizer three times a day for eight weeks
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
living in long-term care, having difficulty swallowing, and requiring assistance
Key exclusion criteria
Persons with diseases affecting Saliva secretion, persons on oxygen therapy
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | Sakai |
Organization
Kyushu University
Division name
Nursing Couse Department of Health Sciences Faculty of Medical Sciences
Zip code
812-8582
Address
3-1-1 Maidashi Higashiku Fukuoka
TEL
092-642-6749
sakai.kumko.528@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Sakai |
Organization
Kyushu University
Division name
Nursing Couse Department of Health Sciences Faculty of Medical Sciences
Zip code
812-8582
Address
3-1-1 Maidashi Higashiku Fukuoka
TEL
092-642-6749
Homepage URL
sakai.kumiko.528@m.kyushu-u
Sponsor or person
Institute
Kyusyu University
Nursing Couse Department of Health Sciences Faculty of Medical Sciences
Institute
Department
Personal name
Kumiko Sakai
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Red Cross Kyushu International College of Nursing Research Ethics Review Committee
Address
1-1 Asty Munakata,Fukuoka
Tel
0940-35-7001
soumu@jrckicn.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
| 2023 | Year | 09 | Month | 12 | 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
23
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Nono
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The data is being analyzed and prepared for publication.
Management information
Registered date
| 2023 | Year | 09 | Month | 12 | Day |
Last modified on
| 2024 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059556
