Effects of a Comprehensive Intervention on Blood Pressure Control in a Primary Care Setting
1 other identifier
interventional
144
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hypertension
1 active site
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, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2002
CompletedFirst Submitted
Initial submission to the registry
July 31, 2013
CompletedFirst Posted
Study publicly available on registry
August 2, 2013
CompletedJanuary 16, 2014
January 1, 2014
2.2 years
July 31, 2013
January 15, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Office Systolic and Diastolic Blood Pressure
Baseline and at 12 Months.
Study Arms (2)
Intervention
EXPERIMENTALPatients in this arm received a comprehensive intervention on hypertension through optimization of drug therapy, introduction of home blood pressure monitoring, and lifestyle guidance.
Control
NO INTERVENTIONPatients randomized in this group did not receive any intervention and treatment continued according to conventional practice.
Interventions
Comprehensive intervention on hypertension through optimization of drug therapy, introduction of home blood pressure monitoring, and lifestyle guidance
Eligibility Criteria
You may qualify if:
- Aged 35-74 years
- Untreated office blood pressure of ≥ 160/100 mmHg or on active antihypertensive treatment.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Finnish Institute for Health and Welfarelead
- City of Turkucollaborator
- Social Insurance Institution, Finlandcollaborator
Study Sites (1)
Population Studies Unit
Turku, 20810, Finland
Related Publications (1)
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.
PMID: 24186848RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antti Jula, MD
Finnish Institute for Health and Welfare
Teemu Niiranen, MD
Finnish Institute for Health and Welfare
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Specialist
Study Record Dates
First Submitted
July 31, 2013
First Posted
August 2, 2013
Study Start
October 1, 2000
Primary Completion
December 1, 2002
Last Updated
January 16, 2014
Record last verified: 2014-01