UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047872 |
|---|---|
| Receipt number | R000054583 |
| Scientific Title | Efficacy of personal health record in hospital readmission at 6 months in cardiovascular disease with lifestyle-related diseases: A randomized clinical trial |
| Date of disclosure of the study information | 2022/05/27 |
| Last modified on | 2024/05/28 11:40:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of personal health record in hospital readmission at 6 months in cardiovascular disease with lifestyle-related diseases: A randomized clinical trial
Acronym
A RCT of PHR in CVD with lifestyle-related diseases
Scientific Title
Efficacy of personal health record in hospital readmission at 6 months in cardiovascular disease with lifestyle-related diseases: A randomized clinical trial
Scientific Title:Acronym
A RCT of PHR in CVD with lifestyle-related diseases
Region
| Japan |
Condition
Condition
Cardiovascular disease
Lifestyle-related disease
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this randomized study is to evaluate the efficacy of personal health record (PHR) in the admission rate at 6 months in cardiovascular disease patients with lifestyle-related diseases. The study also will assess the efficacy in the difference of all-cause death, BNP, blood pressure, HbA1c, LDL-C, triglyceride, adhealance to medication, and frequency of blood sampling, echocardiogram, and nutrition guidance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hospital admission rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
PHR
Interventions/Control_2
Standard care
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. 18 years or old
2. Heart failure and/or angina and/or myocardial infarction requiring hospitalization
3. Hypertension and/or diabetes and/or dyslipidemia
Key exclusion criteria
1. Dementia
2. Participating in other clinical trials
3. Planing hospitalization within 6 months
4. Taking active cancer treatment
5. Not having a smartphone
6. Patient who is considered ineligible for enrolling in the study by a principal investigator or sub-investigator
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Nochioka |
Organization
Tohoku University Hospital
Division name
Cardiovascular medicine
Zip code
9808574
Address
Seiryo-machi 1-1, Aobaku, Sendai
TEL
0227177153
nochioka@cardio.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Nochioka |
Organization
Tohoku University Hospital
Division name
Cardiovascular medicine
Zip code
9808574
Address
Seiryo-machi 1-1, Aobaku, Sendai
TEL
0227177153
Homepage URL
nochioka@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2022 | Year | 05 | 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
Completed
Date of protocol fixation
| 2022 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 27 | Day |
Last modified on
| 2024 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054583
