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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ayatullah Khomaini, MD, Indonesia University
ClinicalTrials.gov Identifier:
NCT01834365
First received: April 10, 2013
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

There is a structured educational effect on blood pressure reduction in elderly hypertensive patients.


Condition Intervention
Hypertension
Other: Structured education
Other: Checklist
Other: Without structure education with checklist

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Structured Education to Decrease Blood Pressure for Hypertension in Elderly : a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Indonesia University:

Primary Outcome Measures:
  • Systolic blood pressure [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    We measure the difference of diastolic blood pressure after 3 Months administration of structured education in elderly with hypertension


Enrollment: 188
Study Start Date: October 2012
Estimated Study Completion Date: May 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Structured education & checklist
Formatted education and checklist every month for 3 months
Other: Structured education
Formatted education about hypertension
Other: Checklist
Active Comparator: Structured education
Formatted education every month for 3 months
Other: Structured education
Formatted education about hypertension
Active Comparator: Without Structured Education with checklist
No structured education with checklist
Other: Without structure education with checklist

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe Dementia
  • Depression
  • Malignant Hypertension
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01834365

Locations
Indonesia
Cipto Mangunkusumo National Hospital Recruiting
Jakarta, Indonesia, 15111
Sponsors and Collaborators
Indonesia University
Investigators
Principal Investigator: Ayatullah Khomaini, MD Faculty of Medicine University of Indonesia
  More Information

Additional Information:
No publications provided

Responsible Party: Ayatullah Khomaini, MD, Effect of Structured Education to Decrease Blood Pressure for Hypertension in Elderly : a randomized controlled trial, Indonesia University
ClinicalTrials.gov Identifier: NCT01834365     History of Changes
Other Study ID Numbers: AKhomaini
Study First Received: April 10, 2013
Last Updated: April 16, 2013
Health Authority: Indonesia: National Agency of Drug and Food Control

Keywords provided by Indonesia University:
Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014