UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045024 |
|---|---|
| Receipt number | R000051428 |
| Scientific Title | TELE cardiac REHAbilitation system using tele-nursing with apple watch-a large prospective randomized study |
| Date of disclosure of the study information | 2021/08/10 |
| Last modified on | 2021/07/31 09:44:40 |
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Basic information
Public title
Development and a Randomized Open-Label Controlled Trial of Remote Cardiac Rehabilitation with Wearable Medical Devices
Acronym
TELE cardiac REHAbilitation system using tele-nursing with apple watch-a large prospective randomized study
Scientific Title
TELE cardiac REHAbilitation system using tele-nursing with apple watch-a large prospective randomized study
Scientific Title:Acronym
TELE-REHA Trial
Region
| Japan |
Condition
Condition
Cardiovascular diseases
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
All death, cardiovascular events
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All death, cardiovascular events
Key secondary outcomes
EFs, e/e', BNP, CRP, PeakVO2, VE-VCO2 slop, muscular mass,EQ5D,ICER
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
remote-cardiac rehabilitation
Interventions/Control_2
outpatient-cardiac rehabilitation
Interventions/Control_3
non-cardiac rehabilitation
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who were discharged home after undergoing cardiac surgery or treatment with cardiac catheterization.
Key exclusion criteria
1) AMI
2) UAP
3) Pregnancy or nursing
4) uncontrolled arrhythmia
5) uncontrolled AS
6) uncontrolled heart failure
7) acute pulmonary thromboembolism
8) acute myocarditis
9) acute aortic dissection
10) difficulty walking
11) lack of mental capacity
12) pacemaker, implantable cardioverter-defibrillator
13) Others
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Atsuko |
| Middle name | |
| Last name | Nakayama |
Organization
Sakakibara Heart Institute
Division name
Cardiac Rehabilitation Department
Zip code
1830003
Address
Asahi-Chou, Fuchu-City
TEL
+81423143111
atsukonakanaka@gmail.com
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Nakayama |
Organization
The University of Tokyo Hospital
Division name
Cardiac Rehabilitation Department
Zip code
1830003
Address
Asahi-Chou, Fuchu-City
TEL
+81423143111
Homepage URL
atsukonakanaka@gmail.com
Sponsor or person
Institute
Sakakibara Heart Institute
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development(AMED)
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
Sakakibara Heart Institute
Address
3-16-1, Asahi-Chou, Fuchu-City
Tel
+81423143111
atsukonakanaka@gmail.com
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
| 2021 | Year | 08 | Month | 10 | 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
| 2021 | Year | 06 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 31 | Day |
Last modified on
| 2021 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051428
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
