UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039007 |
|---|---|
| Receipt number | R000044269 |
| Scientific Title | Effects of remote lifestyle intervention to control coronary risk factors in patients after percutaneous coronary intervention: a pilot non-randomized controlled trial |
| Date of disclosure of the study information | 2019/12/27 |
| Last modified on | 2021/10/25 11:22:24 |
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Basic information
Public title
Remote lifestyle modification to control risk factors for secondary prevention in ischemic heart disease
Acronym
Remote lifestyle intervention for patients with ischemic heart disease
Scientific Title
Effects of remote lifestyle intervention to control coronary risk factors in patients after percutaneous coronary intervention: a pilot non-randomized controlled trial
Scientific Title:Acronym
Remote lifestyle intervention for patients after percutaneous coronary intervention
Region
| Japan |
Condition
Condition
Acute coronary syndrome, Stable angina pectoris
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility and estimate the effect size of remote lifestyle intervention for controlling risk factors in patients with ischemic heart disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Dropout rate
-Login frequency
-Frequency of sensor device use
-Compliance rate of intervention protocol
-Adherence to data entry
-Evaluation period: around 24-month after exercise tolerance test
Key secondary outcomes
-Systolic blood pressure, diastolic blood pressure
-Low-density lipoprotein cholesterol, Non High-density lipoprotein cholesterol
-HbA1c, Fasting blood sugar or Blood sugar 2 hours after eating
-Peak oxygen uptake
-Reduction of body weight (among patients with body mass index >/=24)
-Moderate to vigorous physical activity
-Health-related quality of life
-Hospital Anxiety and Depression Scale
-Evaluation period: around 24-month after exercise tolerance test
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Definition
Intervention: Receive remote lifestyle intervention using web system after discharge
Note
Intervention: Receive remote lifestyle intervention using web system for around 22 weeks after exercise tolerance test. Engaged in Unsupervised exercise by wearing a wrist-watch type pulse monitor. Exercise data are automatically sent to data server via web system. Receive feed back and educational materials per 1 or 2 weeks based on data of exercise, blood pressure, pulse rate, body weight, and exercise.
Interventions/Control_2
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients underwent percutaneous coronary intervention (PCI) for acute coronary syndrome or stable angina pectoris; hope to participate in remote lifestyle intervention after discharge without a plan to participate in outpatient cardiac rehabilitation; do not have exercise (exercise for 30 min or over including brisk walk per set, 3 times or over per week) habit before PCI; provide written informed consent
Key exclusion criteria
Patients showing abnormal cardiovascular response during exercise; not using the Internet at home; not capable of sending an email by smartphone or tablet-type device; not capable of using computer or IoT device due to visual impairment or mental disorder; receiving hemodialysis; considered inappropriate for participating in remote lifestyle intervention by doctor-in-charge
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Sumio |
| Middle name | |
| Last name | Yamada |
Organization
Nagoya University
Division name
Graduate School of Medicine (Health Sciences)
Zip code
461-8673
Address
1-1-20, Daiko-minami, Higashi-ku, Nagoya
TEL
052-719-1346
yamadas@met.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuji |
| Middle name | |
| Last name | Adachi |
Organization
Nagoya University
Division name
Graduate School of Medicine (Health Sciences)
Zip code
461-8673
Address
1-1-20, Daiko-minami, Higashi-ku, Nagoya
TEL
052-719-1876
Homepage URL
t.adachi@met.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Funding support from the Japan Agency for Medical Research and Development
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
The Ethics Committee of Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
052-744-2061
ethics@med.nagoya-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
名古屋ハートセンター（愛知県）、豊橋ハートセンター（愛知県）、岐阜ハートセンター（岐阜県）、名古屋第一病院（愛知県）、海南病院（愛知県）、大垣市民病院（岐阜県）、枚方公済病院（大阪府）、名古屋第二病院（愛知県）、北野病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 05 | 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
| 2019 | Year | 12 | Month | 26 | Day |
Last modified on
| 2021 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044269
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| Registered date | File name |
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