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Effect of Structured Education to Decrease Blood Pressure for Hypertension in Elderly

Primary Purpose

Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Structured education
Checklist
Without structure education with checklist
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subject with age more than 60 years
  • Blood pressure higher than 140/90

Exclusion Criteria:

  • Severe Dementia
  • Depression
  • Malignant Hypertension

Sites / Locations

  • Cipto Mangunkusumo National Hospital Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Structured education & checklist

Structured education

Without Structured Education with checklist

Arm Description

Formatted education and checklist every month for 3 months

Formatted education every month for 3 months

No structured education with checklist

Outcomes

Primary Outcome Measures

Systolic blood pressure
We aim to measure the difference in systolic blood pressure after 3 months administration structured education in elderly with hypertension

Secondary Outcome Measures

Diastolic blood pressure
We measure the difference of diastolic blood pressure after 3 Months administration of structured education in elderly with hypertension

Full Information

First Posted
April 10, 2013
Last Updated
April 16, 2013
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT01834365
Brief Title
Effect of Structured Education to Decrease Blood Pressure for Hypertension in Elderly
Official Title
Effect of Structured Education to Decrease Blood Pressure for Hypertension in Elderly : a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
May 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
There is a structured educational effect on blood pressure reduction in elderly hypertensive patients.
Detailed Description
Eligibility criteria are men and women over 60 years old and available to participate in the study for 3 months with blood pressure higher than 140/90. Exclusion criteria are severe dementia, malignant hypertension, depression Outcome measures are systolic and diastolic blood pressure after 3 months administration of structured education once a month.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Structured education & checklist
Arm Type
Experimental
Arm Description
Formatted education and checklist every month for 3 months
Arm Title
Structured education
Arm Type
Active Comparator
Arm Description
Formatted education every month for 3 months
Arm Title
Without Structured Education with checklist
Arm Type
Active Comparator
Arm Description
No structured education with checklist
Intervention Type
Other
Intervention Name(s)
Structured education
Intervention Description
Formatted education about hypertension
Intervention Type
Other
Intervention Name(s)
Checklist
Intervention Type
Other
Intervention Name(s)
Without structure education with checklist
Primary Outcome Measure Information:
Title
Systolic blood pressure
Description
We aim to measure the difference in systolic blood pressure after 3 months administration structured education in elderly with hypertension
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Diastolic blood pressure
Description
We measure the difference of diastolic blood pressure after 3 Months administration of structured education in elderly with hypertension
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject with age more than 60 years Blood pressure higher than 140/90 Exclusion Criteria: Severe Dementia Depression Malignant Hypertension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayatullah Khomaini, MD
Organizational Affiliation
Faculty of Medicine University of Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cipto Mangunkusumo National Hospital Recruiting
City
Jakarta
ZIP/Postal Code
15111
Country
Indonesia

12. IPD Sharing Statement

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Effect of Structured Education to Decrease Blood Pressure for Hypertension in Elderly

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