UMIN-CTR Clinical Trial

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
Email	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
Email	matsukyuu413@med.nagoya-u.ac.jp

Sponsor
Institute	nagoya university graduate school of medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042749