UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027269 |
|---|---|
| Receipt number | R000031240 |
| Scientific Title | Effect of communication skills of medical staffs on quality of patient-centered medicine |
| Date of disclosure of the study information | 2017/05/15 |
| Last modified on | 2021/05/11 14:31:35 |
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Basic information
Public title
Effect of communication skills of medical staffs on quality of patient-centered medicine
Acronym
Effect of communication skills of medical staffs on quality of patient-centered medicine
Scientific Title
Effect of communication skills of medical staffs on quality of patient-centered medicine
Scientific Title:Acronym
Effect of communication skills of medical staffs on quality of patient-centered medicine
Region
| Japan |
Condition
Condition
diseases causing dysphagia
Classification by specialty
| Oto-rhino-laryngology | Rehabilitation medicine | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
communication skills of medical staffs and patient experience
Basic objectives2
Others
Basic objectives -Others
effect of communication skills of medical staffs after the communication training on patient experience 6 months after the training.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
patient experience survey administered immediately after and 6 months after communication skill training
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) patients cared by participants of the designated communication training
2) ages of 20 years and more
Key exclusion criteria
1) ages less than 20 years
2) adults without adequate ability to judge.
3) adults who need consideration about diagnosis
Target sample size
480
Research contact person
Name of lead principal investigator
| 1st name | Shin-Ichi |
| Middle name | |
| Last name | Izumi |
Organization
Tohoku University Graduate School of Biomedical Engineering
Division name
Physical Medicine and Rehabilitation
Zip code
980-8575
Address
2-1 Seiryo-cho, Aoba-ku, Sendai
TEL
022-717-7338
shinichi.izumi.c2@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Shin-Ichi |
| Middle name | |
| Last name | Izumi |
Organization
Tohoku University Graduate School of Biomedical Engineering
Division name
Physical Medicine and Rehabilitation
Zip code
980-8575
Address
2-1 Seiryo-cho, Aoba-ku, Sendai
TEL
022-717-7338
Homepage URL
shinichi.izumi.c2@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
GlaxoSmithKline plc
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-cho, Aoba-ku, Sendai
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2017 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
https://www.med.tohoku.ac.jp/public/documents/2017.html
Publication of results
Unpublished
Result
URL related to results and publications
https://www.rinri.med.tohoku.ac.jp/esct/Apply/show.aspx?TYPE=6&ID=22056
Number of participants that the trial has enrolled
199
Results
The total CSA plus score(self-rated)was 77.3 (SD = 6.3) points before the course and 103.2(SD = 40.2) points after the course(t-test, P< 0.001),which was significantly higher than that of the participants(44 valid responses). Cooperators(155 valid responses)scored 93.8(SD = 14.3) points before the course and 94.2(SD = 13.8) points after the course, which was not significantly different(t-test, NS). The PX survey had a small number of valid responses, so we're unable to conduct the planned analysis.
Results date posted
| 2020 | Year | 11 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
47 multi-professional medical professionals (physicians, dentists, nurses, speech-language pathologists, dietitians, and dental hygienists) involved in feeding and swallowing rehabilitation
Participant flow
Forty-seven participants in the "Project for Building a Model of Human Resource Development for Practicing Multidisciplinary Cooperation", which has the same purpose as this study, and five collaborators whom the participants considered important for their work, were selected to participate in this study.
Adverse events
none
Outcome measures
CSA plus score
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We measure patient experience cared by medical staffs who participate in the communication skill training immediately after the training and 6 months after the training, and examine relationship between the communication skill and change in patient experience.
Management information
Registered date
| 2017 | Year | 05 | Month | 08 | Day |
Last modified on
| 2021 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031240
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
