Effects of a Comprehensive Intervention on Blood Pressure Control in a Primary Care Setting

January 15, 2014 updated by: Teemu Niiranen, Finnish Institute for Health and Welfare
The implementation of lifestyle modifications, home blood pressure (BP) measurement, and optimization of antihypertensive drug therapy have been shown to improve BP control in tightly controlled research settings. The investigators objective is to determine the effect of these interventions in a primary care setting, with the family practitioners and nurses serving as the interventionists. The investigaotrs hypothesis is that a comprehensive intervention performed in a primary care setting would lead to better blood pressure control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

144

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

  • Finland
      • Turku, Finland, 20810
        • Population Studies Unit

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

35 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 35-74 years
  • Untreated office blood pressure of ≥ 160/100 mmHg or on active antihypertensive treatment.

Exclusion Criteria:

  • Severe psychiatric or neurologic illnesses
  • Heart failure (ejection fraction < 40% or previous hospitalization for heart failure)
  • Hemodynamically significant valvular disease
  • Unstable coronary heart disease
  • Chronic kidney disease (proteinuria > 1 g/l or a serum creatinine concentration > 160 mmol/l)

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Patients in this arm received a comprehensive intervention on hypertension through optimization of drug therapy, introduction of home blood pressure monitoring, and lifestyle guidance.
Other: Intensive Care
Comprehensive intervention on hypertension through optimization of drug therapy, introduction of home blood pressure monitoring, and lifestyle guidance
No Intervention: Control
Patients randomized in this group did not receive any intervention and treatment continued according to conventional practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Office Systolic and Diastolic Blood Pressure
Time Frame: Baseline and at 12 Months.
Baseline and at 12 Months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Finnish Institute for Health and Welfare

Collaborators

Social Insurance Institution, Finland
City of Turku

Investigators

  • Principal Investigator: Antti Jula, MD, Finnish Institute for Health and Welfare
  • Teemu Niiranen, MD, Finnish Institute for Health and Welfare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2000

Primary Completion (Actual)

December 1, 2002

Study Registration Dates

First Submitted

July 31, 2013

First Submitted That Met QC Criteria

August 1, 2013

First Posted (Estimate)

August 2, 2013

Study Record Updates

Last Update Posted (Estimate)

January 16, 2014

Last Update Submitted That Met QC Criteria

January 15, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UVEL

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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