NCT02032472

Brief Summary

Background: Hypertension in adults is the factor most prevalent cardiovascular risk and motivates further inquiries, generating a very high cost of medical care. Objective: To evaluate the monitoring of well-controlled hypertensive patients Pharmacy Offices. Hypothesis: the monitoring of these patients through the Office of Pharmacy will be as effective in obtaining good control of blood pressure as it is to obtained through health centers. Design: Multicenter randomized controlled trial along one year of follow up. Location: the city of Cerdanyola del Vallès (Barcelona). Participants: All patients diagnosed with hypertension and good control criteria in the past year. Arms: Health centers (control) and Pharmacy Offices (intervention). Outcome variable: blood pressure under good control along the monitoring

Trial Health

87
On Track

Trial Health Score

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

Enrollment
677

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 10, 2014

Completed
Last Updated

January 10, 2014

Status Verified

January 1, 2014

Enrollment Period

1.9 years

First QC Date

December 23, 2013

Last Update Submit

January 7, 2014

Conditions

Hypertension

Keywords

Blood Pressure Monitoring, AmbulatoryArterial PressureHypertension ControlledPharmacies

Outcome Measures

Primary Outcomes (1)

  • Percentage of hypertensive patients with criteria for good control of their arterial pressure along one year follow up

    We considered as a for good control criterion , obtaining values of systolic arterial pressure to below 140 mm Hg and diastolic blood pressure below 90 mm Hg dea, held along the entire the year follow-up of patients

    Monitoring of patients for 12 months (from January 1 to December 31, 2010)

Secondary Outcomes (1)

  • reduction in the number of visits to the health center to measure blood pressure

    Monitoring of patients for 12 months (from January 1 to December 31, 2010)

Study Arms (2)

Health Center (usual practice)

NO INTERVENTION

Controlling arterial pressure in the health center (a common practice is carried out)

Collaboration of pharmacies

EXPERIMENTAL

Pharmacies cooperate in Measurement of Arterial Pressure of patients

Other: Measurement of Arterial Pressure

Interventions

Measurement of Arterial PressureOTHER

Pharmacies cooperate in measuring blood pressure of patients

Collaboration of pharmacies

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age not less than 18 years
  • HTA controlled over 2 years of evolution
  • Subjects with a history open to participating health centers or stable residence in the geographic area
  • Subjects who agree to participate

You may not qualify if:

  • Comorbidity and concomitant (Diabetes Mellitus, Heart failure or renal failure
  • Patients with temporary residence in the geographic area of study
  • Subjects of hypertension controlled by outside professionals to our primary care teams.
  • Subjects with home care or any other cause which does not permit their displacement, transfer to the clinic or pharmacy during the evaluation period.
  • Subjects with severe diseases of poor prognosis, hopefully less than one year of life.
  • Subjects who do not have telephones.
  • Subjects with communication problems (cognitive impairment, sensory, language barrier)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Català de la Salut (ICS)

Cerdanyola Del Valllés, Barcelona, 08290, Spain

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Oscar Solans, G Physician

    Institut Català de la Salut (Spain)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2013

First Posted

January 10, 2014

Study Start

January 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

January 10, 2014

Record last verified: 2014-01

Locations

ES(1)