UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042275 |
|---|---|
| Receipt number | R000047976 |
| Scientific Title | Effects of remote patient management on cardiac disease: A randomized controlled trial |
| Date of disclosure of the study information | 2020/10/29 |
| Last modified on | 2022/05/02 10:18:14 |
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Basic information
Public title
Effects of remote patient management on cardiac disease: A randomized controlled trial
Acronym
Remote patient management trial
Scientific Title
Effects of remote patient management on cardiac disease: A randomized controlled trial
Scientific Title:Acronym
Remote patient management trial
Region
| Japan |
Condition
Condition
Cardiac disease
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of remote patients management program on the prevention of physical function deterioration in patients with cardiac disease
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in the five time sit to stand test, a component of the Short Physical Performance Battery (SPPB)
Key secondary outcomes
Overall satisfaction with remote patients management program
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Vaccine | Behavior,custom |
Interventions/Control_1
"Outpatient group" continues to exercise program on an outpatient basis for a month
Interventions/Control_2
"Remote patients management group" receives one month of remote support using a telemedicine system
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Age between 20 and 85 years old at the time of obtaining consent
(2) No events occur during outpatient 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 remote support
Key exclusion criteria
(1) Patients with neuromuscular abnormalities that interfere with walking
(2) Those with vision problems such as not being able to see the screen of a tablet device for remote assistance
(3) Hearing problems such as inability to listen to voice during remote assistance
(4) Others who are deemed unsuitable as research subjects by the attending physician or principal investigator.
Target sample size
46
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
Medical Policy Bureau, Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2020 | Year | 10 | Month | 29 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8827239/
Publication of results
Partially published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8827239/
Number of participants that the trial has enrolled
11
Results
All participants completed the intervention without serious adverse event in each group. After the on-site initial remote system set up, all the patients completed the Remote-CR session without on-site assistance. Patients' satisfaction with Remote-CR was generally high. Remote-CR helps to maintain healthy lifestyle behavior. In addition, Remote-CR and CB-CR seem to be equally successful in maintaining functional status and preventing cardiovascular-related hospital readmission.
Results date posted
| 2022 | Year | 05 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Between October 2020 and February 2021, we enrolled older patients with cardiac disease after at least over 5 months of ambulatory CR program.
Participant flow
The study was conducted as a randomized controlled case series to compare Remote-CR vs. center-based CR (CB-CR) after ambulatory CR in older patients with cardiac disease.
Adverse events
Non
Outcome measures
We evaluated the satisfaction of Remote-CR, and impact of Remote-CR on adherence to exercise and physical activity management. Moreover, we assessed the change in functional status using handgrip strength, usual gait speed, short physical performance battery (SPPB), and Kihon checklist (KCL) before the intervention, at the end of the 4-week intervention, and cardiovascular-related hospital discharge within 6 months after completion of ambulatory CR.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 29 | Day |
Last modified on
| 2022 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047976
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| Registered date | File name |
| Research case data | |
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