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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044120
Receipt No. 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 2021/05/06

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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 Basic 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
Email 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
Email te-takahashi@juntendo.ac.jp

Sponsor
Institute Faculty of Health Science
Department of Physical Therapy
Juntendo University
Institute
Department

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
Email 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
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 Enrolling by invitation
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
2023 Year 03 Month 31 Day
Date of closure to data entry
2023 Year 05 Month 31 Day
Date trial data considered complete
2023 Year 05 Month 31 Day
Date analysis concluded
2023 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2021 Year 05 Month 06 Day
Last modified on
2021 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050377

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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