UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031486 |
|---|---|
| Receipt number | R000035936 |
| Scientific Title | Development of the self-care supporting program by the collaborative partnership approach for patients who have just had coronary artery bypass graft surgery |
| Date of disclosure of the study information | 2018/02/26 |
| Last modified on | 2021/08/30 11:32:38 |
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Basic information
Public title
Development of the self-care supporting program by the collaborative partnership approach for patients who have just had coronary artery bypass graft surgery
Acronym
Development of the self-care supporting program for patients who have just had coronary artery bypass graft surgery
Scientific Title
Development of the self-care supporting program by the collaborative partnership approach for patients who have just had coronary artery bypass graft surgery
Scientific Title:Acronym
Development of the self-care supporting program for patients who have just had coronary artery bypass graft surgery
Region
| Japan |
Condition
Condition
coronary artery bypass graft surgery
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Develop the self-care supporting program by collaborative partnership approach for patients who have just had coronary artery bypass graft surgery, and examine the efficacy of the program
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
self-care agency(one month and three months after leaving the hospital)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
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
Provide the knowledge of self-care using the pamphlet (twice)
Teach how to self-monitor their health condition (twice)
Discuss the goal in daily life together (twice)
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Being physically independent on daily life before hospitalization
Key exclusion criteria
Dialysis patients
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | Ogata |
Organization
Fukuoka University
Division name
School of Nursing, Faculty of Medicine
Zip code
8140180
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan
TEL
092-801-1011
kuogata@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Ogata |
Organization
Fukuoka University
Division name
School of Nursing, Faculty of Medicine
Zip code
8140180
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan
TEL
092-801-1011
Homepage URL
kuogata@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University,
School of Nursing, Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of science
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
Fukuoka University Clinical Research & Ethics Centre
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan
Tel
092-801-1011
fumed-ethics@fukuoka-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
福岡大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 26 | 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 | 03 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | 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 | 02 | Month | 26 | Day |
Last modified on
| 2021 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035936
