- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01834365
Effect of Structured Education to Decrease Blood Pressure for Hypertension in Elderly
April 16, 2013 updated by: Ayatullah Khomaini, MD, Indonesia University
Effect of Structured Education to Decrease Blood Pressure for Hypertension in Elderly : a Randomized Controlled Trial
There is a structured educational effect on blood pressure reduction in elderly hypertensive patients.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
188
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Jakarta, Indonesia, 15111
- Cipto Mangunkusumo National Hospital Recruiting
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject with age more than 60 years
- Blood pressure higher than 140/90
Exclusion Criteria:
- Severe Dementia
- Depression
- Malignant Hypertension
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Structured education & checklist
Formatted education and checklist every month for 3 months
|
Formatted education about hypertension
|
Active Comparator: Structured education
Formatted education every month for 3 months
|
Formatted education about hypertension
|
Active Comparator: Without Structured Education with checklist
No structured education with checklist
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systolic blood pressure
Time Frame: 3 Months
|
We aim to measure the difference in systolic blood pressure after 3 months administration structured education in elderly with hypertension
|
3 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diastolic blood pressure
Time Frame: 3 Months
|
We measure the difference of diastolic blood pressure after 3 Months administration of structured education in elderly with hypertension
|
3 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ayatullah Khomaini, MD, Faculty of Medicine University of Indonesia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
February 1, 2013
Study Completion (Anticipated)
May 1, 2013
Study Registration Dates
First Submitted
April 10, 2013
First Submitted That Met QC Criteria
April 16, 2013
First Posted (Estimate)
April 17, 2013
Study Record Updates
Last Update Posted (Estimate)
April 17, 2013
Last Update Submitted That Met QC Criteria
April 16, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AKhomaini
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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