UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A shared decision making communication training program for clinicians treating: a pilot clustered randomised controlled trial
Title of the study (Brief title)	A shared decision making communication training program
Region	Japan

Condition
Condition	Stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of a communication training program for facilitating shared decision making skills in clinicians and their patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The 9-item SDM Questionnaire
Key secondary outcomes	Outcome measures were Autonomy Preference Index, Patient Satisfaction Questionnaire, Functional Independent Measurement, Fugl-Meyer Assessment, The General Health Questionnaire at 2 weeks folow-up.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	YES
Institution consideration
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Education program (communication) one hour
Interventions/Control_2	Education program (stroke) one hour
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Eligible therapists 1)informed and asked for participation 2)stroke Eligible patients 1)informed and asked for participation 2)be in the charge of eligible therapists
Key exclusion criteria	Eligible therapists 1)assigned to this study group Eligible patients 1)assigned to either the group as the object of the study 2)cannot be taken communicate 3)be determined to be inappropriate
Target sample size	35

Research contact person
Name of lead principal investigator	Noriko Kon
Organization	Kawakita Rehabilitation Hospital
Division name	department of therapy
Address	1-9-27, Horinouchi, Suginami, Tokyo
TEL	03-5307-5151
Email	nobinobi.00.nontan.sc@gmail.com

Public contact
Name of contact person	Noriko Kon
Organization	Kawakita Rehabilitation Hospital
Division name	department of therapy
Address	1-9-27, Horinouchi, Suginami, Tokyo
TEL	03-5307-5151
Homepage URL
Email	nobinobi.00.nontan.sc@gmail.com

Sponsor
Institute	Kawakita Rehabilitation Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	河北リハビリテーション病院

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 30 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 06 Month 30 Day
Anticipated trial start date	2016 Year 07 Month 30 Day
Last follow-up date	2016 Year 11 Month 30 Day
Date of closure to data entry	2016 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded	2017 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 21 Day
Last modified on	2016 Year 06 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025946