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

NCT ID: NCT01915199

Last Updated: 2014-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Intensive Care

Intervention Type OTHER

Comprehensive intervention on hypertension through optimization of drug therapy, introduction of home blood pressure monitoring, and lifestyle guidance

Control

Patients randomized in this group did not receive any intervention and treatment continued according to conventional practice.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intensive Care

Comprehensive intervention on hypertension through optimization of drug therapy, introduction of home blood pressure monitoring, and lifestyle guidance

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

35 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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City of Turku

OTHER_GOV

Sponsor Role collaborator

Social Insurance Institution, Finland

OTHER

Sponsor Role collaborator

Finnish Institute for Health and Welfare

OTHER_GOV

Sponsor Role lead

Responsible Party

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Teemu Niiranen

Medical Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antti Jula, MD

Role: PRINCIPAL_INVESTIGATOR

Finnish Institute for Health and Welfare

Teemu Niiranen, MD

Role:

Finnish Institute for Health and Welfare

Locations

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Population Studies Unit

Turku, , Finland

Site Status

Countries

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Finland

References

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Niiranen TJ, Leino K, Puukka P, Kantola I, Karanko H, Jula AM. Lack of impact of a comprehensive intervention on hypertension in the primary care setting. Am J Hypertens. 2014 Mar;27(3):489-96. doi: 10.1093/ajh/hpt204. Epub 2013 Nov 1.

Reference Type RESULT
PMID: 24186848 (View on PubMed)

Other Identifiers

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UVEL

Identifier Type: -

Identifier Source: org_study_id

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