UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044369 |
|---|---|
| Receipt number | R000050681 |
| Scientific Title | A pilot study to evaluate the efficacy of personal health record to healthcare quality in cardiovascular disease patients with lifestyle diseases |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2023/05/25 09:28:40 |
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Basic information
Public title
A pilot study to evaluate the efficacy of personal health record to healthcare quality in cardiovascular disease patients with lifestyle diseases
Acronym
PHRASAL Pilot Study
Scientific Title
A pilot study to evaluate the efficacy of personal health record to healthcare quality in cardiovascular disease patients with lifestyle diseases
Scientific Title:Acronym
PHRASAL Pilot Study
Region
| Japan |
Condition
Condition
Cardiovascular disease
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the efficacy of personal health record (PHR) on controlling life-style related diseases in patients with cardiovascular disease. We also will assess patients' attitude, confidence, understanding and motivation toward PHR.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure, body weight, HbA1c, LDL-C, HDL-C, TG, and BNP levels at 6 months
Key secondary outcomes
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Personal health record
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with cardiovascular diseases at Tohoku University Hospital
2. 20 years of age or older
3. Women and men
4. Patients or their family caregiver have to have the smart phone
Key exclusion criteria
1. Patients who do not give written informed consent
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Nochioka |
Organization
Tohoku University Hospital
Division name
Cardiovascular division
Zip code
9808574
Address
Seiryou-machi 1-1, Aobaku Sendai, Miyagi, Japan
TEL
+81227177153
nochioka@cardio.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | NOCHIOKA |
| Last name | Nochioka |
Organization
Tohoku University Hospital
Division name
Cardiovascular division
Zip code
9808574
Address
Seiryou-machi 1-1, Aobaku Sendai, Miyagi, Japan
TEL
+81227177153
Homepage URL
nochioka@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development (AMED)
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
Seiryo-machi 1-1, Aobaku Sendai, Miyagi
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
東北大学大学院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 01 | 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
| 2021 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2023 | 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
| 2021 | Year | 05 | Month | 30 | Day |
Last modified on
| 2023 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050681
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
