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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035898
Receipt No. 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 2019/03/07

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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.Quality of life (EQ-5D-5L)
5.Self-efficacy (GSES)
6.Medication-taking adherence (MMAS-4)
7.Medical cost
8.Adverse events
9.Change in number or dosage of antihypertensive medicine
10.Days until change of antihypertensive medicine after the start of clinical study
11.Self-monitoring data
12.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
Middle name
Last name Toshihisa Anzai
Organization Hokkaido University
Division name Department of Cardiovascular Medicine, Faculty of Medicine and Graduate School of Medicine
Zip code
Address Kita-15 Nishi-7, Kita-Ku, Sapporo 060-8638, Japan
TEL 011-706-6973
Email anzai@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Yokota
Organization Hokkaido University
Division name Department of Cardiovascular Medicine, Faculty of Medicine and Graduate School of Medicine
Zip code
Address Kita-15 Nishi-7, Kita-Ku, Sapporo 060-8638, Japan
TEL 011-706-6973
Homepage URL
Email t-yokota@med.hokudai.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Institute
Department

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
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 01 Month 29 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 02 Month 17 Day
Last modified on
2019 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040740

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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