UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041687 |
|---|---|
| Receipt number | R000047586 |
| Scientific Title | Multimodal comprehensive care methodology training on oral health care professionals |
| Date of disclosure of the study information | 2020/09/06 |
| Last modified on | 2022/04/13 10:38:05 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Multimodal comprehensive care methodology training on oral health care professionals
Acronym
Humanitude Dental Study
Scientific Title
Multimodal comprehensive care methodology training on oral health care professionals
Scientific Title:Acronym
Humanitude Dental Study
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Geriatrics | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is designed to evaluate the effect of multimodal comprehensive care methodology on dental health care professionals and their patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The empathy of dental health care professionals to their patients in 1 month.
Key secondary outcomes
Oral health of their patients
Dementia Stigma Scale
Difficulty score of providing the care
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
To provide one-day multimodal comprehensive care methodology training
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Dental healthcare professionals who are taking care of elderly dementia patients regularly.
2) Enable to give written consent.
Key exclusion criteria
1)A person who does not give written consent.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Mio |
| Middle name | |
| Last name | Ito |
Organization
Tokyo Metropolitan Institute of gerontology
Division name
Research on Social and Human Sciences
Zip code
1730015
Address
2-5-1 Higashigaoka, Meguro, Tokyo
TEL
0339643241
mioito@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Miwako |
| Middle name | |
| Last name | Honda |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Division of Geriatric Research
Zip code
1520021
Address
2-5-1 Higashigaoka, Meguro, Tokyo
TEL
03-3411-0111
Homepage URL
honda-1@umin.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of gerontology
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Institute of Gerontology
Address
35-2 Sakae, Itabashi, Tokyo
Tel
0339643241
mioito@gunma-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
| 2020 | Year | 09 | Month | 06 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/34082730/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34082730/
Number of participants that the trial has enrolled
45
Results
Results: The post-training response rate was 87% (21 dentists and 18 dental hygienists). From pre-training to post-training, the multimodal comprehensive care methodology training significantly increased the mean empathy score (from 113.97 to 122.95, P < 0.05, effect size = 0.9).
Results date posted
| 2022 | Year | 04 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Methods: This research was a pre-post prospective study.
Participant flow
A total of 45 dentists and dental hygienists participated in a 7-h multimodal comprehensive care methodology training programme.
Adverse events
none
Outcome measures
Results: The post-training response rate was 87% (21 dentists and 18 dental hygienists). From pre-training to post-training, the multimodal comprehensive care methodology training significantly increased the mean empathy score (from 113.97 to 122.95, P < 0.05, effect size = 0.9). Regardless of gender, profession and years of clinical experience, all post-training subgroup scores were higher than the pre-training subgroup scores. The tongue, natural teeth, and oral hygiene scores of patients with dementia who resisted usual oral care or dental treatment, as assessed by the OHAT, were significantly improved compared with those before the training.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 04 | Day |
Last modified on
| 2022 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047586
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/04/13 | 12909_2021_Article_2760.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2022/04/13 | 12909_2021_Article_2760.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2022/04/13 | 12909_2021_Article_2760.pdf |
