UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056130 |
|---|---|
| Receipt number | R000064094 |
| Scientific Title | Research on the Challenges and Utilization of Practical Knowledge in Lifestyle Guidance Using Digital Therapeutics for Hypertension |
| Date of disclosure of the study information | 2024/11/12 |
| Last modified on | 2024/11/12 14:08:45 |
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Basic information
Public title
Research on the Challenges and Utilization of Practical Knowledge in Lifestyle Guidance Using Digital Therapeutics for Hypertension
Acronym
Research on the Challenges and Utilization of Practical Knowledge in Lifestyle Guidance Using Digital Therapeutics for Hypertension
Scientific Title
Research on the Challenges and Utilization of Practical Knowledge in Lifestyle Guidance Using Digital Therapeutics for Hypertension
Scientific Title:Acronym
Research on the Challenges and Utilization of Practical Knowledge in Lifestyle Guidance Using Digital Therapeutics for Hypertension
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify the challenges and approaches in overall lifestyle guidance for hypertension in clinical settings, as well as the actual utilization and challenges of using CureApp HT.
Basic objectives2
Others
Basic objectives -Others
questionnaire survey and interviews
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
answers to questions about lifestyle guidance
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthcare professionals who provide lifestyle modification guidance to hypertensive patients and are affiliated with medical institutions that have prescribed the 'CureApp HT Hypertension Treatment Support App' to patients between September 1, 2022, and September 30, 2024.
Key exclusion criteria
None
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Fumi |
| Middle name | |
| Last name | Hisaki |
Organization
CureApp, Inc.
Division name
Medical Division
Zip code
1030001
Address
4F, 12-5, Nihonbashikodenmacho, Chuo-ku, Tokyo, Japan
TEL
0362310183
ht_medical-affairs@cureapp.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Hirayama |
Organization
CureApp, Inc.
Division name
Medical Division
Zip code
1030001
Address
4F, 12-5, Nihonbashikodenmacho, Chuo-ku, Tokyo, Japan
TEL
0362310183
Homepage URL
ht_medical-affairs@cureapp.jp
Sponsor or person
Institute
CureApp, Inc.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hillside Clinic Jingumae Ethics Committe
Address
4-22-11 Jingumae, Shibuya-ku, Tokyo
Tel
03-6779-8166
chi-pr-ec-hillside@cmicgroup.com
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
| 2024 | Year | 11 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collect narrative information on the phenomenon from research participants using open-ended questionnaires and semi-structured interviews, either individually or in groups. Employ a grounded theory approach to categorize challenges, their factors, and approaches.
Management information
Registered date
| 2024 | Year | 11 | Month | 12 | Day |
Last modified on
| 2024 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064094
