Efficiency of Monitoring and Control Program of Hypertension Through Pharmacy Offices. APOF Project (APOF)

Efficiency Program Monitoring and Control of Hypertension Through Pharmacy Offices. APOF Project

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Other: Measurement of Arterial Pressure

• Study Type: Interventional
• Enrollment (Actual): 677
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Cerdanyola del Valllés, Barcelona, Spain, 08290
      • Institut Català de la Salut (ICS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Health Center (usual practice); Controlling arterial pressure in the health center (a common practice is carried out)
Experimental: Collaboration of pharmacies; Pharmacies cooperate in Measurement of Arterial Pressure of patients	Other: Measurement of Arterial Pressure; Pharmacies cooperate in measuring blood pressure of patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
reduction in the number of visits to the health center to measure blood pressure	The number of visits to the health center where blood pressure is measured. We hope that the number of visits to the health center where blood pressure is measured is lower in the intervention group (the patients have the option to go to the pharmacy to carrying out checks blood pressure)	Monitoring of patients for 12 months (from January 1 to December 31, 2010)

Collaborators and Investigators

• Sponsor: Jordi Gol i Gurina Foundation
• Collaborators: Institut Catala de Salut
• Investigators: Principal Investigator: Oscar Solans, G Physician, Institut Català de la Salut (Spain)

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: December 23, 2013
• First Submitted That Met QC Criteria: January 7, 2014
• First Posted (Estimate): January 10, 2014

Study Record Updates

• Last Update Posted (Estimate): January 10, 2014
• Last Update Submitted That Met QC Criteria: January 7, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Blood Pressure Monitoring, Ambulatory; Pharmacies; Arterial Pressure; Hypertension Controlled
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: APOF_IDIAP