UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030855 |
|---|---|
| Receipt number | R000035230 |
| Scientific Title | Supplemental Pamphlet Illustrating Cardiopulmonary Resuscitation for Advanced Directive |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2020/07/19 22:45:29 |
* 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
Supplemental Pamphlet Illustrating Cardiopulmonary Resuscitation for Advanced Directive
Acronym
SPICRAD
Scientific Title
Supplemental Pamphlet Illustrating Cardiopulmonary Resuscitation for Advanced Directive
Scientific Title:Acronym
SPICRAD
Region
| Japan |
Condition
Condition
Advanced directive
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether utilising a pamphlet illustrating the overview of cardiopulmonary resuscitation improve patient's or the surrogate's understanding of cardiopulmonary resuscitation (main study).
To find out whether introducing a pamphlet illustrating the overview of cardiopulmonary resuscitation into practice decrease doctor's burden of explanation (substudy).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient's or the surrogate's objective understanding
Key secondary outcomes
1. Patient's or the surrogate's subjective comprehensibility of doctor's explanation
2. Patient's or the surrogate's anxiety
3. Code status of cardiopulmonary arrest
4. Doctor's subjective burden
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Introducing a pamphlet with the overview of cardiopulmonary resuscitation and recommend doctors in
General Internal Medicine to use to explain what cardiopulmonary resuscitation is to the patient or the surrogate while filling Advanced directives.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inpatients in general internal medicine ward
Patients filled advanced directive at Kameda Medical Centre for the first time
Key exclusion criteria
Having received explanation of CPR before
Refused to answer
Incompletely filled questionaire
No consent from doctors providing care to the patients
Explanation of CPR was done with no meeting
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Qianzhi Wang |
Organization
Kameda Medical Center
Division name
Postgraduate Education Center
Zip code
Address
929 Higashicho, Kamogawa, Chiba, Japan
TEL
+81470922211
kennoo177@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Qianzhi Wang |
Organization
Kameda Medical Center
Division name
Postgraduate Education Center
Zip code
Address
929 Higashicho, Kamogawa, Chiba, Japan
TEL
+81470922211
Homepage URL
kennoo177@gmail.com
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
亀田総合病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 01 | 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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 17 | Day |
Last modified on
| 2020 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035230
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
