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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043786
Receipt No. 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 2021/03/30

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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 is 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 An oral health evaluation using OHAT 5 , a subjective evaluation of thirst, and 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 effect significantly 21-day predicting 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 The inclusion criteria were palliative care patients who have been requested by the attending physician or the nurse in charge to intervene in the palliative care team of our hospital
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
Email 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
Email nakao.mifumi.qk@mail.hosp.go.jp

Sponsor
Institute national hospital organization kumamoto medical center
Institute
Department

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
Email 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
2021 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049978

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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