UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044120 |
|---|---|
| Receipt number | R000050377 |
| Scientific Title | Effectiveness of tele-rehabilitation for early prevention of worsening of care needs in patients with heart disease |
| Date of disclosure of the study information | 2021/05/06 |
| Last modified on | 2024/12/03 14:02:58 |
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Basic information
Public title
Effectiveness of tele-rehabilitation for early prevention of worsening of care needs in patients with heart disease
Acronym
Tele-Rehab for Prevention of Care Needs Worsening
Scientific Title
Effectiveness of tele-rehabilitation for early prevention of worsening of care needs in patients with heart disease
Scientific Title:Acronym
Effectiveness of tele-rehabilitation for early prevention of worsening of care needs in patients with heart disease
Region
| Japan |
Condition
Condition
Cardiac disease
Classification by specialty
| Cardiology | Cardiovascular surgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the effects of tele-rehabilitation on promoting the regaining of physical functions and preventing the worsening of care needs in patients with cardiac disease after discharge from hospital
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Kihon checklist 6 months after discharge
Key secondary outcomes
Short Physical Performance Battery (SPPB)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
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
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
"Tele-Rehab group" receives one month of tele-rehabilitation service support using a tele-communication system
Interventions/Control_2
Control group
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Age between 65 and 90 years old at the time of obtaining consent
(2) No events occur during in-patient cardiac rehabilitation
(3) Those who, after receiving a full explanation of their participation in this study, have obtained written consent of their own free will with a full understanding of the research subject.
(4) Family members who can help with tele-rehabilitation service
Key exclusion criteria
(1) Patients who have not been able to walk independently before hospitalization
(2) Those with vision problems such as not being able to see the screen of a tablet device for tele-rehabilitation service
(3) Hearing problems such as inability to listen to voice during tele-rehabilitation
(4) Others who are deemed unsuitable as research subjects by the attending physician or principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Takahashi |
Organization
Juntendo University
Division name
Faculty of Health Science, Department of Physical Therapy
Zip code
1130033
Address
3-2-12 Hongo Bunkyo-ku, Tokyo
TEL
03-5802-0425
te-takahashi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Takahashi |
Organization
Juntendo University
Division name
Faculty of Health Science, Department of Physical Therapy
Zip code
1130033
Address
3-2-12 Hongo Bunkyo-ku, Tokyo
TEL
03-5802-0425
Homepage URL
te-takahashi@juntendo.ac.jp
Sponsor or person
Institute
Faculty of Health Science
Department of Physical Therapy
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Hospital Ethics Committee
Address
3-1-3 Hongo Bunkyo-ku, Tokyo
Tel
03-5802-1584
kenkyu5858@juntendo.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
順天堂大学医学部附属順天堂医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 06 | 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
80
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
Main results already published
Date of protocol fixation
| 2021 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 06 | Day |
Last modified on
| 2024 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050377
