UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037376 |
|---|---|
| Receipt number | R000042523 |
| Scientific Title | Application and evaluation of a personalized training program to facilitate discharge for implanted ventricular assist device(VAD) patients, especially with postoperative physical and/or higher cerebral dysfunctions. |
| Date of disclosure of the study information | 2019/07/14 |
| Last modified on | 2019/07/14 21:17:47 |
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Basic information
Public title
Application and evaluation of a personalized training program to facilitate discharge for implanted ventricular assist device(VAD) patients, especially with postoperative physical and/or higher cerebral dysfunctions.
Acronym
Effectiveness of new training program for i-VAD patients.
Scientific Title
Application and evaluation of a personalized training program to facilitate discharge for implanted ventricular assist device(VAD) patients, especially with postoperative physical and/or higher cerebral dysfunctions.
Scientific Title:Acronym
Effectiveness of new training program for i-VAD patients.
Region
| Japan |
Condition
Condition
Patients who newly implanted i-VAD at Tohoku university hospital and discharge their home.
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effectiveness and afety of the personalized training program for i-VAD patients to facilitate their discharge.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
A difference in ratio of patients whose postoperative hospital stay is more than 100 days between before and after introduction of the training program.
Key secondary outcomes
Changes in each training step by the personalized training program.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
1:In preoperative and/or postoperative period, nurses assess whether physical and/or higher cerebral dysfunctions in iVAD patients is present or not, using a chekulist.
2:Specially for the patients with postoperative dysfunctions, nurses correct and set each personalized goal after discussion with multidisiplinary team consisted of medical doctors nurses, transplant coordinator, physical therapist and medical engineers.
3:To implement the new training program to all iVAD patients.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Historical study grope: The patients who implanted iVAD from 2008 to 2017 at Tohoku university hospital.
2 The patients who newly implant iVAD after 2019 and receive this personalized training program.
Key exclusion criteria
Patients who have more than 2 time experience of VAD implanteation.
Patients who is not good at communicating in Japanese
Reserch patients
Patients who implanted iVAD at other hospitals.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Michiyo |
| Middle name | |
| Last name | Abe |
Organization
TOhoku university hospital Nursing division
Division name
East 9 ward
Zip code
9808574
Address
1-1 Seiryo-machi Aoba-ku Sendai Miyagi
TEL
022-717-7000
akiko-kusakari.b2@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yuzi |
| Middle name | |
| Last name | Matushima |
Organization
TOhoku university hospital Nursing division
Division name
East 9 ward
Zip code
9808574
Address
1-1 Seiryo-machi Aoba-ku Sendai Miyagi
TEL
0227177000
Homepage URL
kusakari-akiko.b2@tohoku.ac.jp
Sponsor or person
Institute
Tohoku university hospital
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
Tohoku university hospital
Address
1-1 Seiryo-machi Aoba-ku Sendai Miyagi
Tel
0227284105
rinri-2@proj.med.tohoku.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 | 07 | Month | 14 | 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
| 2019 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 07 | 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
| 2019 | Year | 07 | Month | 14 | Day |
Last modified on
| 2019 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042523
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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