UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035898 |
|---|---|
| Receipt number | R000040740 |
| Scientific Title | Effects of Smartphone Application-Based Integrated Self-Care Support System for Hypertensive Patients |
| Date of disclosure of the study information | 2019/02/18 |
| Last modified on | 2023/05/13 22:09:28 |
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Basic information
Public title
Effects of Smartphone Application-Based
Integrated Self-Care Support System
for Hypertensive Patients
Acronym
AppCare-HT Study
Scientific Title
Effects of Smartphone Application-Based
Integrated Self-Care Support System
for Hypertensive Patients
Scientific Title:Acronym
AppCare-HT Study
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether smartphone application-based integrated self-care support system may reduce blood pressure in hypertensive patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in systolic blood pressure from baseline to 12 months
Key secondary outcomes
1.Change in systolic blood pressure from baseline to 6 months
2.Change in diastolic blood pressure from baseline to each follow-up point (6 months and 12 months)
3.Change in frequency of blood pressure measurements at home from baseline to each follow-up point (6 months and 12 months)
4.Systolic blood pressure
5.Diastolic blood pressure
6.Frequency of blood pressure measurements at home
7.Quality of life (EQ-5D-5L)
8.Self-efficacy (GSES)
9.Medication-taking adherence (MMAS-4)
10.Medical cost
11.Adverse events
12.Change in number or dosage of antihypertensive medicine
13.Days until change of antihypertensive medicine after the start of clinical study
14.Self-monitoring data
15.Frequency of use of smartphone application
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Application group
Interventions/Control_2
Non-application group (control group)
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
Hypertensive patients whose blood pressure at the clinic or physical check-up is more than 140/90mmHg irrespective of taking antihypertensive agents
Key exclusion criteria
1.A patient who cannot use smartphone application
2.A patient diagonized as secondary hypertension
3.A patient with chronic atrial fibrillation
4.A patient with severe renal failure (eGFR<15mL/min/1.73m2) or a dialysis patient
5.A patient who has a history of major cardiovascular events within the past 3 months
6.A patient whose antihypertensive medication was changed within the past 1 month
7.A patient who has a plan of hospitalization due to surgery or examination at the time of study participation
8.A patient who is using another smartphone application for hypertension at the time of study participation
9.A patients who is judged as inappropriate for the study participation by the principal investigator
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | Toshihisa |
| Middle name | |
| Last name | Anzai |
Organization
Hokkaido University
Division name
Department of Cardiovascular Medicine, Faculty of Medicine and Graduate School of Medicine
Zip code
060-8638
Address
Kita-15 Nishi-7, Kita-Ku, Sapporo, Japan
TEL
011-706-6973
anzai@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Yokota |
Organization
Hokkaido University
Division name
Department of Cardiovascular Medicine, Faculty of Medicine and Graduate School of Medicine
Zip code
060-8638
Address
Kita-15 Nishi-7, Kita-Ku, Sapporo, Japan
TEL
011-706-6973
Homepage URL
t-yokota@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
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)
Japan Science and Technology Agency
IRB Contact (For public release)
Organization
Hokkaido University Hospital Certified Review Board
Address
Kita-14 Nishi-5, Kita-Ku, Sapporo 060-8648, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2019 | Year | 02 | Month | 18 | 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
360
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 25 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 25 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 17 | Day |
Last modified on
| 2023 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040740
| Research Plan | |
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| 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 |
