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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014