NCT01834365

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
188

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2013

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

April 17, 2013

Status Verified

April 1, 2013

Enrollment Period

4 months

First QC Date

April 10, 2013

Last Update Submit

April 16, 2013

Conditions

Hypertension

Keywords

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Systolic blood pressure

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

    3 Months

Secondary Outcomes (1)

  • Diastolic blood pressure

    3 Months

Study Arms (3)

Structured education & checklist

EXPERIMENTAL

Formatted education and checklist every month for 3 months

Other: Structured educationOther: Checklist

Structured education

ACTIVE COMPARATOR

Formatted education every month for 3 months

Other: Structured education

Without Structured Education with checklist

ACTIVE COMPARATOR

No structured education with checklist

Other: Without structure education with checklist

Interventions

Structured educationOTHER

Formatted education about hypertension

Structured educationStructured education & checklist
ChecklistOTHER
Structured education & checklist
Without structure education with checklistOTHER
Without Structured Education with checklist

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Severe Dementia
  • Depression
  • Malignant Hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo National Hospital Recruiting

Jakarta, 15111, Indonesia

Location

MeSH Terms

Conditions

Hypertension

Interventions

Checklist

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data CollectionHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Ayatullah Khomaini, MD

    Faculty of Medicine University of Indonesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Effect of Structured Education to Decrease Blood Pressure for Hypertension in Elderly : a randomized controlled trial

Study Record Dates

First Submitted

April 10, 2013

First Posted

April 17, 2013

Study Start

October 1, 2012

Primary Completion

February 1, 2013

Study Completion

May 1, 2013

Last Updated

April 17, 2013

Record last verified: 2013-04

Locations

ID(1)