UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050019 |
|---|---|
| Receipt number | R000056954 |
| Scientific Title | The effect of self-management support on facial expression in the hypertensive patients |
| Date of disclosure of the study information | 2023/01/15 |
| Last modified on | 2024/03/28 12:17:45 |
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Basic information
Public title
The effect of self-management support on facial expression in the hypertensive patients
Acronym
The effect of self-management support on facial expression in the hypertensive patients
Scientific Title
The effect of self-management support on facial expression in the hypertensive patients
Scientific Title:Acronym
The effect of self-management support on facial expression in the hypertensive patients
Region
| Japan |
Condition
Condition
Essential hypertension
Classification by specialty
| Cardiology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the educational effect of the changes in facial expression in hypertensive patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The percentage of happiness of the facial expression in patients at the second interview (2-3 months later) compared with the first interview
Key secondary outcomes
1)The scores in a self-management scale, blood pressure, medication compliance, the sodium excretion by sodium concentrations of spot urine at the second interview (2-3 months later) compared with the first interview
2)Words by the nurse that induced positive facial expressions in a patient at the interview.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
1) To take a video of the facial expression with self-management support (eating, exercise, stress, medications, alcohol intake, smoking) at the first interview
2) To take a video of the facial expression while talking about daily life after the first interview at the second interview (2-3 months later)
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)outpatients with hypertension
2)patients who had systolic blood pressure more than 135mmHg and/or diastolic blood pressure more than 85mmHg
3)Patients with over 140 mmHg in systolic blood pressure and/or over 90 mmHg in diastolic blood pressure at a hospital, in the case of patients who have not measured blood pressure at home
4)from 20 to 70 years old
5)The follow-up period is 2 to 3 months
Key exclusion criteria
1)patients who have changed the medication at the first interview
2)patients who consult other departments
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Tsubota |
Organization
University of Toyama
Division name
Fundamental Nursing 2
Zip code
930-0194
Address
2630 Sugitani, Toyama 930-0194, Japan
TEL
076-434-2281
yokoda@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Tsubota |
Organization
University of Toyama
Division name
Fundamental Nursing 2
Zip code
930-0194
Address
2630 Sugitani, Toyama 930-0194, Japan
TEL
076-434-2281
Homepage URL
yokoda@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
University of Toyama
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Toyama
Address
2630 Sugitani, Toyama 930-0194, Japan
Tel
076-415-8857
rinri@adm.u-toyama.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 | 01 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2025 | 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 | 01 | Month | 12 | Day |
Last modified on
| 2024 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056954
| Research Plan | |
|---|---|
| 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 |
