UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037687 |
|---|---|
| Receipt number | R000042749 |
| Scientific Title | Patient Perceptions of family physician's empathy: a quasi-randomized controlled trial of physician attire in primary care |
| Date of disclosure of the study information | 2019/08/14 |
| Last modified on | 2021/04/02 15:39:34 |
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Basic information
Public title
Effect of family physician's attire on empathy
Acronym
EFPAE study
Scientific Title
Patient Perceptions of family physician's empathy: a quasi-randomized controlled trial of physician attire in primary care
Scientific Title:Acronym
PPFPE study
Region
| Japan |
Condition
Condition
outpatient
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will show that whether white coat or casual clothes are effective for the patient's perception of family physician's empathy.
Basic objectives2
Others
Basic objectives -Others
In Japan, many doctors choose white coats for medical examinations.
However,some family physicians prefer casual clothes to white coat because of empathy.
There is a previous reseach that white coat is more empathic than casual style in Korea.
But many physicain belive that the casual style is more empathic than white coat in Japan.
The Consultation and Relational Empathy (CARE) Measure is a widely used patient-reported measure that has been extensively validated.
We will show that whether white coat or casual style is more empathic using CARE Measure.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Difference between average points of CARE Measure in white coat group and casual group after consultation
Key secondary outcomes
Subgroup analysis of age,sex,reasons for consultation (acute or chronic diseases), preconceptions and preferences about the clothes of doctors.
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Family physicians with casual style examine patients.
Casual style is defined as collared shirts should be worn instead of white coats and ties.
Whether or not a physician wear face mask is standardized for each doctor.
Interventions/Control_2
Family physicians with white coat style examine patients.The white coat group is defined as wearing a white coat. There is no special provision for clothes under the white coat.
Whether or not a physician wear face mask is standardized for each doctor.
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
First-visit adult outpatients examined by a family doctor who works at the clinic
Key exclusion criteria
Patients who have difficulty answering questionnaires due to dementia or mental illness or severe acute illness.
Patients who need questionnaire support, such as those with severe visual or hearing impairment.
Patients who visit for vaccination or medical checkup.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Takaharu |
| Middle name | |
| Last name | Matsuhisa |
Organization
nagoya university hospital
Division name
department of general medicine
Zip code
466-8560
Address
65 Tsurumai-cho,Showa-ku,Nagoya
TEL
052-744-2951
matsukyuu413@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Takaharu |
| Middle name | |
| Last name | Matsuhisa |
Organization
nagoya university hospital
Division name
department of general medicine
Zip code
466-8560
Address
65 Tsurumai-cho,Showa-ku,Nagoya
TEL
052-744-2951
Homepage URL
matsukyuu413@med.nagoya-u.ac.jp
Sponsor or person
Institute
nagoya university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
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
nagoya university hospital
Address
65 Tsurumai-cho,Showa-ku,Nagoya
Tel
052-744-2951
ethics@med.nagoya-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
| 2019 | Year | 08 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://bmcfampract.biomedcentral.com/articles/10.1186/s12875-021-01416-w
Number of participants that the trial has enrolled
637
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 03 | Month | 31 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 10 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 22 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 22 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 23 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 14 | Day |
Last modified on
| 2021 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042749
