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

Hypertension Clinical Trial

— APOF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02032472
• Other study ID #: APOF_IDIAP
• Status: Completed
• Phase: N/A
• First received: December 23, 2013
• Last updated: January 7, 2014
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: January 2014
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 677
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• Measurement of Arterial Pressure
Pharmacies cooperate in measuring blood pressure of patients

Locations

Country	Name	City	State
Spain	Institut Català de la Salut (ICS)	Cerdanyola del Valllés	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Institut Catala de Salut

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No