UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039837 |
|---|---|
| Receipt number | R000045386 |
| Scientific Title | Effectiveness of medication guidance using Nudge theory for hypertensive patients |
| Date of disclosure of the study information | 2020/03/17 |
| Last modified on | 2020/09/26 22:41:53 |
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Basic information
Public title
Effectiveness of medication guidance using Nudge theory for hypertensive patients
Acronym
Effectiveness of medication guidance using Nudge theory
Scientific Title
Effectiveness of medication guidance using Nudge theory for hypertensive patients
Scientific Title:Acronym
Effectiveness of medication guidance using Nudge theory
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To consider effectiveness of medication guidance using Nudge theory
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Behavior change stage model(next medication guidance)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
We are going to do normal medication guidance for hypertension patients one time.(S group)
Interventions/Control_2
We are going to do medication guidance using Nudge theory for hypertension patients one time. (N 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who use one or some antihypertensive drugs
Key exclusion criteria
Patients who can't judge their own participation of this research.
When the research responsible person is absence and patients who write the research questionnaire for the first time.
Patients who write the research questionnaire for the second time after the research finished.
Patients who use only beta(alpha beta)blocker drugs or Diuretic drugs for hypertension treatment.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Shusei |
| Middle name | |
| Last name | Nagashima |
Organization
GAIENKIKAKUSYOJI CO., LTD.
Division name
WAKABA Pharmacy PARKVIEW
Zip code
270-0152
Address
Folia Station F2, 154-1, Maehirai, Nagareyama-shi, Chiba
TEL
04-7128-9861
nudge401@gmail.com
Public contact
Name of contact person
| 1st name | Shusei |
| Middle name | |
| Last name | Nagashima |
Organization
GAIENKIKAKUSYOJI CO., LTD.
Division name
WAKABA Pharmacy PARKVIEW
Zip code
270-0152
Address
Folia Station F2, 154-1, Maehirai, Nagareyama-shi, Chiba
TEL
04-7128-9861
Homepage URL
nudge401@gmail.com
Sponsor or person
Institute
GAIENKIKAKUSYOJI CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
GAIENKIKAKUSYOJI CO., LTD.
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
Chiba Pharmacist Association
Address
9-2, Tonyacho, Chiba Chuo-ku, Chiba
Tel
043-247-4401
drug-info@c-yaku.or.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
| 2020 | Year | 03 | Month | 17 | 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
71
Results
The changes in the contents of the first and second responses in each group were compared, but no significant difference was found between the groups in the behavioral change stage model and the degree of behavioral change on the Likert scale.
Line up terms of interest in descending order, exercise, low salt, alcohol saving, and smoking cessation were high, and the composition ratio did not change in two surveys.
Results date posted
| 2020 | Year | 05 | Month | 31 | Day |
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
| 2019 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 10 | Day |
Date of closure to data entry
| 2020 | Year | 05 | Month | 18 | Day |
Date trial data considered complete
| 2020 | Year | 05 | Month | 19 | Day |
Date analysis concluded
| 2020 | Year | 05 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 16 | Day |
Last modified on
| 2020 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045386
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/05/31 | 研究計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
