UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028981 |
|---|---|
| Receipt number | R000033159 |
| Scientific Title | Development of Nursing Care Program with Diabetes Oral Health Assessment Tool |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2022/04/07 20:21:17 |
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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
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
kuwamura.yumi@tokushima-u.ac.jp
Sponsor or person
Institute
Department of Women's Health Nursing, Institute of Biomedical Sciences,Tokushima University Graduate School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033159
| 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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