UMIN-CTR Clinical Trial

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
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	2022 Year 01 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049978