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Psychometric Testing of the Korean version of the Self-care of Hypertension Inventory scale

Status Approved

First Submitted Date

2020/11/03
Registered Date

2020/12/01
Last Updated Date

2020/11/03

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005648
Unique Protocol ID	KHNMC 2020-09-018-001
Public/Brief Title	Psychometric Testing of the Korean version of the Self-care of Hypertension Inventory scale
Scientific Title	Psychometric Testing of the Korean version of the Self-care of Hypertension Inventory scale
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	KHNMC 2020-09-18-001
Approval Date	2020-10-20
Institutional Review Board Name	Kyung Hee University at Gangdong Institutional Review Board
Institutional Review Board Address	892, Dongnam-ro, Gangdong-gu, Seoul
Institutional Review Board Telephone	02-440-8107
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Aekyung Chang
Title	Assciate professor
Telephone	+82-2-961-9589
Affiliation	Kyung Hee University
Address	26, Kyungheedae-ro, Dongdaemun-gu, Seoul, Republic of Korea
Contact Person for Public Queries
Name	Yookyung Jin
Title	graduate student
Telephone	+82-2-2036-0418
Affiliation	Kyung Hee University
Address	26, Kyungheedae-ro, Dongdaemun-gu, Seoul, Republic of Korea
Contact Person for Updating Information
Name	Yookyung Jin
Title	graduate student
Telephone	+82-2-2036-0418
Affiliation	Kyung Hee University
Address	26, Kyungheedae-ro, Dongdaemun-gu, Seoul, Republic of Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2020-12-01 Anticipated
Target Number of Participant	300
Primary Completion Date	2020-12-31 , Anticipated
Study Completion Date	2021-10-19 , Anticipated
Name of Study	Kyung Hee University Hospital at Gangdong
Recruitment Status	Recruiting
Date of First Enrollment	2020-12-01 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Kyung Hee University
Organization Type	University
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Kyung Hee University
Organization Type	University

7. Study Summary

Study Summary Information
Lay Summary	The prevalence of hypertension worldwide is estimated to be 31.1%, and in Korea, the prevalence of hypertension among adults over the age of 30 increased from 24.5% in 2007 to 28.3% in 2018. It is reported that only 44% are controlling the high blood pressure awareness rate compared to 68%. If the level of awareness and control for hypertension is not optimal, the prevalence of hypertension is expected to continue to rise. In this study, in order to evaluate self-care of hypertensive patients, the Korean version of the SC-HI was developed as a relatively concise tool of 23 questions and proved its reliability and validity. We want to verify the reliability and validity of HI and explore the applicability of the inventory.

Study Summary Information

Lay Summary

The prevalence of hypertension worldwide is estimated to be 31.1&#37;, and in Korea, the prevalence of hypertension among adults over the age of 30 increased from 24.5&#37; in 2007 to 28.3&#37; in 2018. It is reported that only 44&#37; are controlling the high blood pressure awareness rate compared to 68&#37;. If the level of awareness and control for hypertension is not optimal, the prevalence of hypertension is expected to continue to rise.

In this study, in order to evaluate self-care of hypertensive patients, the Korean version of the SC-HI was developed as a relatively concise tool of 23 questions and proved its reliability and validity. We want to verify the reliability and validity of HI and explore the applicability of the inventory.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Cohort
Time Perspective	Cross-sectional
Target Number of Participant	300
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label Adult subjects diagnosed with hypertension
Cohort/ Group 1	Cohort/Group Description The reliability and validity of the hypertension self-care measurement tool was verified by conducting two surveys on the overall self-management of hypertension in domestic hypertensive patients.
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Adult subjects diagnosed with hypertension among outpatients at one general hospital in S City
Sampling Method	Convenience Sampling
Condition(s)/Problem(s)	* (I00-I99)Diseases of the circulatory system (I10.9)Other and unspecified primary hypertension Self-management of chronically ill patients
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 18Year~100Year
	Description Adults over 18 years old Those who have been diagnosed with high blood pressure
Exclusion Criteria	Those who are unable to complete a questionnaire because communication is impossible
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	Reliability of the Korean version of the hypertension self-care inventory (SC-HI)
Timepoint	At the time of visit
Secondary Outcome(s) 1
Outcome	Validity of the Korean version of the hypertension self-care inventory (SC-HI)
Timepoint	At the time of visit

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Yes
Time of Sharing	2021. 12
Way of Sharing	Available on Request (akchang@khu.ac.kr)

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