UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043786 |
|---|---|
| Receipt number | R000049978 |
| Scientific Title | Association of poor oral health with overall mortality in palliative care patients |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2022/01/26 15:03:53 |
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Basic information
Public title
Association of poor oral health with overall mortality in palliative care patients admitted to acute hospitals
Acronym
Oral health and mortality in palliative care
Scientific Title
Association of poor oral health with overall mortality in palliative care patients
Scientific Title:Acronym
oral health and mortality in palliative care
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to investigate the association of oral health with overall survival and determine the optimal cutoff values of oral health assessment tool (OHAT) scores for predicting mortality in palliative care patients.
Basic objectives2
Others
Basic objectives -Others
Oral health appraisal using OHAT 5 , a subjective assessment of thirst, an oral candidiasis test, and PS and food intake were evaluated at the time of team intervention.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The total OHAT score might significantly predict 21-day mortality.
Key secondary outcomes
Some elements of OHAT might significantly affect the prediction 21-day mortality.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Palliative care patients who had been requested by the attending physician or nurse in charge to intervene in the palliative care team of our hospital were included in this study.
Key exclusion criteria
Exclusion criteria were (1) ongoing chemotherapy and (2) severe mental illness.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | takeshi |
| Middle name | |
| Last name | nakashima |
Organization
national hospital organization kumamoto medical center
Division name
dentistry and oral surgery
Zip code
860-0008
Address
1-5, ninomaru, tyuuouku, kumamoto-city, kumamoto prefecture
TEL
096-353-6501
nakashima.takeshi.fm@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | mifumi |
| Middle name | |
| Last name | nakao |
Organization
national hospital organization kumamoto medical center
Division name
dentistry and oral surgery
Zip code
860-0008
Address
1-5, ninomaru, tyuuouku, kumamoto-city, kumamoto prefecture
TEL
0963536501
Homepage URL
nakao.mifumi.qk@mail.hosp.go.jp
Sponsor or person
Institute
national hospital organization kumamoto medical center
Institute
Department
Personal name
Funding Source
Organization
No organization
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
national hospital organization kumamoto medical center
Address
1-5, ninomaru, tyuuouku, kumamoto-city,
Tel
0963536501
nakashima.takeshi.fm@mail.hosp.go.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 | 04 | Month | 01 | 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
176
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
| 2017 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective observational study was conducted in an acute hospital with palliative care team, and 176 consecutive palliative care patients were included between April 2017 and March 2020. Oral health was measured using OHAT. Prediction accuracy was evaluated by the area under curve.
Management information
Registered date
| 2021 | Year | 03 | Month | 30 | Day |
Last modified on
| 2022 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049978
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
