UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022832 |
|---|---|
| Receipt number | R000025946 |
| Scientific Title | A shared decision making communication training program for clinicians treating: a pilot clustered randomised controlled trial |
| Date of disclosure of the study information | 2016/06/30 |
| Last modified on | 2016/06/21 23:36:59 |
* 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
A shared decision making communication training program for clinicians treating: a pilot clustered randomised controlled trial
Acronym
A shared decision making communication training program
Scientific Title
A shared decision making communication training program for clinicians treating: a pilot clustered randomised controlled trial
Scientific Title:Acronym
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.
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
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
| 1st name | |
| Middle name | |
| Last name | Noriko Kon |
Organization
Kawakita Rehabilitation Hospital
Division name
department of therapy
Zip code
Address
1-9-27, Horinouchi, Suginami, Tokyo
TEL
03-5307-5151
nobinobi.00.nontan.sc@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko Kon |
Organization
Kawakita Rehabilitation Hospital
Division name
department of therapy
Zip code
Address
1-9-27, Horinouchi, Suginami, Tokyo
TEL
03-5307-5151
Homepage URL
nobinobi.00.nontan.sc@gmail.com
Sponsor or person
Institute
Kawakita Rehabilitation Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2016 | Year | 06 | Month | 30 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025946
