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The Effect of Pharmacist Intervention on Blood Pressure Control (AFenPA)

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ClinicalTrials.gov Identifier: NCT01233193
Recruitment Status : Unknown
Verified February 2010 by Universidad de Granada.
Recruitment status was:  Active, not recruiting
First Posted : November 3, 2010
Last Update Posted : May 6, 2016
Sponsor:
Information provided by:
Universidad de Granada

Brief Summary:
The purpose of the study is to test if a Pharmacist Intervention Program with home blood pressure monitoring (HBPM) improves or controls pharmacological adherence and blood pressure levels in hypertensive patients under pharmacological treatment, compared to those who receive usual care in a community pharmacy setting.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Health education, Home blood pressure monitoring Not Applicable

Detailed Description:
Hypertension is a major health concern worldwide due to its deleterious impact on the population in terms of excessive morbidity and mortality, especially when there is insufficient hypertension control and prevention at the community level.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pharmacist Intervention Effect on the Medication Adherence and Blood Pressure Control in Treated Patients
Study Start Date : February 2010
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

Arm Intervention/treatment
Experimental: Intervention
The intervention group receive an pharmacist intervention (health education, Home Blood Pressure Monitoring and Referral to physician as needed) This group will be followed for 6 months
Behavioral: Health education, Home blood pressure monitoring
Health education (on hypertension, smoking, healthy diet, obesity, physical inactivity and adherence to antihypertensive medications and home blood pressure monitoring) . The patient will be referred to physician when needed. The patient will be followed up during 6 months.
Other Name: pharmaceutical health education
No Intervention: Control
The control group receive usual care in the community pharmacy



Primary Outcome Measures :
  1. blood pressure control [ Time Frame: At 6 months ]
    Percentage of patients with controlled hypertension


Secondary Outcome Measures :
  1. Adherence [ Time Frame: At 6 months ]
    Percentage of adherent patients after 6 months within the trial



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of both genders between the ages of 18 and 80 years, who access the pharmacy to fill their own prescription for hypertension.

Exclusion criteria:

  • Patient living with an other Hypertensive patient treated with the same medications
  • Pregnant women
  • Hypertensive patients with levels of systolic/diastolic blood pressure ≥ 180mmHg/110mmHg
  • Patient with secondary hypertension, kidney or liver failure
  • Patients already included in a care program for hypertensive patients
  • Patients with a new treatment for hypertension (less than 1 month)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01233193


Locations
Spain
Community Pharmacies
Granada, Andalucia, Spain, 18000
Community Pharmacies
Jaén, Andalucia, Spain, 23000
Sponsors and Collaborators
Universidad de Granada
Investigators
Study Director: Maria Jose Faus, PhD Universidad de Granada

Responsible Party: María José Faus Dáder, Pharmaceutical Care Research Group of the University of Granada
ClinicalTrials.gov Identifier: NCT01233193     History of Changes
Other Study ID Numbers: DMM01-FAR-10
First Posted: November 3, 2010    Key Record Dates
Last Update Posted: May 6, 2016
Last Verified: February 2010

Keywords provided by Universidad de Granada:
Home blood pressure measurement
Pharmaceutical Services
Medication adherence
hypertension management
Blood Pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases