UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055823 |
|---|---|
| Receipt number | R000063805 |
| Scientific Title | A Randomized Controlled Trial on the Effectiveness of Innovative Health Enhancement and Cardiac Rehabilitation Support Program Combining a Personal Health Record App and Counseling Services for Patients with Ischemic Heart Disease |
| Date of disclosure of the study information | 2024/10/13 |
| Last modified on | 2025/07/11 17:09:36 |
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Basic information
Public title
A Randomized Controlled Trial on the Effectiveness of Innovative Health Enhancement and Cardiac Rehabilitation Support Program Combining a Personal Health Record App and Counseling Services for Patients with Ischemic Heart Disease
Acronym
REVIVE HEART PHR
Scientific Title
A Randomized Controlled Trial on the Effectiveness of Innovative Health Enhancement and Cardiac Rehabilitation Support Program Combining a Personal Health Record App and Counseling Services for Patients with Ischemic Heart Disease
Scientific Title:Acronym
REVIVE HEART PHR
Region
| Japan |
Condition
Condition
Ischemic Heart Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of a continuous support program that integrates a PHR app and counseling services in improving the continuation rate of outpatient cardiac rehabilitation and exercise tolerance in patients with IHD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in Peak Oxygen Uptake (Peak VO2) from baseline to 150 days post-participation
Key secondary outcomes
Change in Anaerobic Threshold (AT) from baseline to 150 days
Number of outpatient cardiac rehabilitation visits over 150 days
Actual versus target rehabilitation visit rate over 150 days
Change in average daily steps from baseline over 150 days
Number of nutritional and medication guidance sessions during outpatient visits
Changes in body weight from baseline to final rehabilitation
Changes in blood pressure from baseline to final rehabilitation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Intervention Group: Participants will receive an iPhone, a weighing scale, a blood pressure monitor and a PHR app for smart phone. These devices directly link with the PHR app and transmit data automatically. In addition, the participants receive the telephone counseling services. The telephone counseling assists with the installation and setup of the devices and the PHR app. Furthermore, participants receive phone calls to discuss healthy lifestyle choices and monitor their participation in cardiac rehabilitation by trained counselors per two weeks.The PHR app: Heart club will collect and visualize daily weight, blood pressure, pulse rate, and step counts, which will be shared with medical staff and telephone counselor via the "Cardiac Rehab Board."
Interventions/Control_2
Control Group: Participants will receive a wearable device (smartwatch, blood pressure monitor, and scale) without access to the PHR app and counseling services. A one-time phone call will ensure proper device usage and a support desk will be available for any device-related inquiries.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who have undergone percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for acute coronary syndrome (ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, unstable angina) or those with chronic ischemic heart failure, regardless of initial or recurrent episodes.
2. 18 years or older.
3. Ability to visit the collaborating research institutions.
4. Those using iPhone 13 or later models
Key exclusion criteria
1. Individuals not eligible for insurance coverage of outpatient cardiac rehabilitation.
2. Diagnosis of dementia.
3. Inability to walk independently to the hospital.
4. Inability to understand Japanese.
5. Other conditions deemed inappropriate by the principal investigator.
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Iwami |
Organization
Kyoto University
Division name
Department of Preventing Services, School of Public Health
Zip code
602-8032
Address
Yoshida-konoe cho, Sakyo Ward, Kyoto
TEL
09059378076
yoshimuras1986@gmail.com
Public contact
Name of contact person
| 1st name | Yoshimura |
| Middle name | |
| Last name | Satoshi |
Organization
Kyoto University, School of Public Health
Division name
Department of Preventive Services
Zip code
606-8315
Address
Yoshida-konoe cho, Sakyo Ward, Kyoto
TEL
075-753-2426
Homepage URL
revive_heart@yobou.med.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
HealthTech laboratory, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
| 2024 | Year | 10 | Month | 13 | 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
| 2024 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Individual participant data (IPD) that underlie the results reported in this article will be made available upon reasonable request from the corresponding author. Data will be de-identified and shared with researchers who provide a methodologically sound proposal, following approval by the institutional review board.
Management information
Registered date
| 2024 | Year | 10 | Month | 13 | Day |
Last modified on
| 2025 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063805
