UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052578 |
|---|---|
| Receipt number | R000060000 |
| Scientific Title | A pilot study to examine the impact of a pedometer app with financial incentives on blood pressure |
| Date of disclosure of the study information | 2023/10/23 |
| Last modified on | 2024/10/22 20:47:03 |
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Basic information
Public title
A pilot study to examine the impact of a pedometer app with financial incentives on blood pressure
Acronym
A pilot study to examine the impact of a pedometer app with financial incentives on blood pressure
Scientific Title
A pilot study to examine the impact of a pedometer app with financial incentives on blood pressure
Scientific Title:Acronym
A pilot study to examine the impact of a pedometer app with financial incentives on blood pressure
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the impact of a pedometer app with financial incentives on blood pressure in subjects with mild hypertension.
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 8 weeks of app use
Key secondary outcomes
Change in diastolic blood pressure from baseline to 8 weeks of app use
Change in systolic blood pressure from baseline to 4 weeks of app use
Change in diastolic blood pressure from baseline to 4 weeks of app use
Change in body weight from baseline to 4 weeks of app use
Change in body weight from baseline to 8 weeks of app use
Correlation between the average number of successful weekly challenges and the change in systolic blood pressure.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Use of a smartphone app that measures moderate physical activity and provides financial incentives based on exercise time
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.aged 40 to 65 at the time of inclusion
2.systolic blood pressure between 130 mmHg and 159 mmHg at the time of inclusion
3.able to walk independently without the use of a walking aid
4.able to communicate, read and write in Japanese
5.owns an iPhone and can agree to carry it at all times during the study period
6.do not own a smartwatch, or if they do, are willing to consent to unpair their smartwatch from their iPhone during the study
7.can provide written consent to participate in the study of his/her own free will
Key exclusion criteria
1.already exercising at least 3 days a week
2.prohibited from exercising by a physician for any reason
3.systolic blood pressure 160 mmHg or higher or diastolic blood pressure 100 mmHg or higher at the time of inclusion
4.already taking antihypertensive medication
5.diagnosed with angina
6.has experienced chest pain or shortness of breath during labor
7.has a history of syncope during exercise
8.has a history of arrhythmia or palpitations
9.has heart murmurs on auscultation
10.diagnosed with chronic kidney disease or diabetes mellitus.
11.diagnosed with secondary hypertension or suspected based on medical history.
12.judged by the investigator to be ineligible for participation in the study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kosuke |
| Middle name | |
| Last name | Hayashi |
Organization
Oita University Faculty of Medicine
Division name
Department of Clinical Pharmacology and Therapeutics
Zip code
8795593
Address
1-1 Idaigaoka, Hasama-Machi, Yufu-Shi, Oita, 879-5593 Japan
TEL
0975865952
khayashi@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Hayashi |
Organization
Oita University Faculty of Medicine
Division name
Department of Clinical Pharmacology and Therapeutics
Zip code
8795593
Address
1-1 Idaigaoka, Hasama-Machi, Yufu-Shi, Oita, 879-5593 Japan
TEL
0975865952
Homepage URL
khayashi@oita-u.ac.jp
Sponsor or person
Institute
Oita University Faculty of Medicine
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
Oita University Hospital, Clinical Trial Ethics Committee
Address
1-1 Idaigaoka, Hasama-Machi, Yufu-Shi, Oita, 879-5593 Japan
Tel
0975866163
gcrcjimu@oita-u.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
| 2023 | Year | 10 | Month | 23 | 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
Terminated
Date of protocol fixation
| 2023 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 23 | 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
| 2023 | Year | 10 | Month | 23 | Day |
Last modified on
| 2024 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060000
