UMIN-CTR Clinical Trial

Basic information
Public title	Development of Nursing Care Program with Diabetes Oral Health Assessment Tool
Acronym	Development of Diabetes Oral Health Nursing Care Program
Scientific Title	Development of Nursing Care Program with Diabetes Oral Health Assessment Tool
Scientific Title:Acronym	Development of Diabetes Oral Health Nursing Care Program
Region	Japan

Condition
Condition	diabetes
Classification by specialty	Endocrinology and Metabolism Dental medicine Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Development of Nursing Support Program with Diabetes Oral Health Assessment Tool, and examine the effect of the program.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Primary outcomes is the awareness of oral health behaviors (of doing oral health behaviors) of the patients with diabetes. The times of evaluation are 3 month, 6 monthe, 12 month after educational intervention.
Key secondary outcomes	oral subjective symptoms, information transmission regarding dental visits, perceptions and knowledge of oral health,complicatuins, treatment, HbA1c, tne number of teeth, attending the diabetes class, dental visiting

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Educating the patients with diabetes about the importance of oral health behaviors for 4 times;first, 3 monthes later, 6 months later, 12 months later with leaflets, toothburush, supplementary tools.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	The persons who were diagnosed with diabetes and treated in the hospital (both of inpatients and outpatients) and who agreed to participate in this study.
Key exclusion criteria	(1)The persons who were judgmented by the doctors and nurses that it is not good to participate the study because of mental and physical desease will be excluded. (2)The persons who can not do oral self care by themselves (judgmented by the doctors and nurses) will be excluded. (3)The persons who can not see the agreement sheets,because of low vision will be excluded.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Yumi Middle name Last name Kuwamura
Organization	Tokushima University
Division name	Graduate School, Department of Women's Health Nursing, Institute of Biomedical Sciences
Zip code	770-8509
Address	3-18-15, Kuramoto-cho, Tokishima-city, Tokushima, 770-8509. JAPAN
TEL	+81-88-633-7647
Email	kuwamura.yumi@tokushima-u.ac.jp

Public contact
Name of contact person	1st name Yumi Middle name Last name Kuwamura
Organization	Tokushima University
Division name	Graduate School, Department of Women's Health Nursing, Institute of Biomedical Sciences
Zip code	770-8509
Address	3-18-15, Kuramoto-cho, Tokishima-city, Tokushima, 770-8509. JAPAN
TEL	+81-88-633-7647
Homepage URL
Email	kuwamura.yumi@tokushima-u.ac.jp

Sponsor
Institute	Department of Women's Health Nursing, Institute of Biomedical Sciences,Tokushima University Graduate School
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical research ethics review board of the Tokushima University Hospital Clinical Trial Center for Developmental Therapeutics
Address	2-50-1, Kuramoto-cho, Tokishima-city, Tokushima, 770-8503. JAPAN
Tel	+81-88-633-9294
Email	awachiken@tokushima-u.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	2018 Year 04 Month 01 Day

Related information
URL releasing protocol	https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_rec_f5.cgi
Publication of results	Published

Result
URL related to results and publications	https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_rec_f5.cgi
Number of participants that the trial has enrolled	75
Results	After the intervention, there were significant improvements in the total score of M-DiOHAT(C) and the motivation stage of changes in oral health behaviors between the baseline and 12 months later. Eight participants who had not visited the dentist in the previous year at the baseline visited the dentist. (It was presented at 63rd Annual Meeting of the Japan Diabetes Society by WEB by virtual presentation. Currently submitting a manuscript.)
Results date posted	2020 Year 09 Month 05 Day
Results Delayed	Delay expected
Results Delay Reason	Because we are analzing the results, after we finished collecting the data.
Date of the first journal publication of results	2022 Year 03 Month 28 Day
Baseline Characteristics	Participants were recruited from a diabetes outpatient clinic in an education and research hospital in western Japan. The inclusion criteria for participant recruitment were (a) aged over twenty years, diagnosed with diabetes, and treated at the outpatient clinic; (b) agreed to participate; (c) had more than 1 tooth; and (d) had no possibility of changes in their physical condition through participation in the study as determined by their diabetes physicians.
Participant flow	Data were collected at baseline and 3, 6, and 12 months after the baseline. The content of the diabetes oral nursing intervention program was as follows: (1) questions about M-DiOHAT (C)questionnaire and other things, (2) education about the M-DiOHAT(C). All of the programs were conducted.
Adverse events	Nothing.
Outcome measures	The primary outcomes were oral health perceptions and behaviors evaluated by the scale of M-DiOHAT(C). Secondary outcomes included motivation, dental visits, number of teeth, and Hemoglobin A1c(HbA1c).
Plan to share IPD	Nothing.
IPD sharing Plan description	Nothing.

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 06 Month 04 Day
Date of IRB	2017 Year 10 Month 02 Day
Anticipated trial start date	2022 Year 06 Month 30 Day
Last follow-up date	2022 Year 06 Month 30 Day
Date of closure to data entry	2022 Year 06 Month 30 Day
Date trial data considered complete	2022 Year 06 Month 30 Day
Date analysis concluded	2022 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date	2017 Year 09 Month 04 Day
Last modified on	2022 Year 04 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033159