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

May 5, 2016 updated by: Universidad de Granada

Pharmacist Intervention Effect on the Medication Adherence and Blood Pressure Control in Treated Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Andalucia
      • Granada, Andalucia, Spain, 18000
        • Community pharmacies
      • Jaén, Andalucia, Spain, 23000
        • Community pharmacies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • pharmaceutical health education
No Intervention: Control
The control group receive usual care in the community pharmacy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood pressure control
Time Frame: At 6 months
Percentage of patients with controlled hypertension
At 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: At 6 months
Percentage of adherent patients after 6 months within the trial
At 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Granada

Investigators

  • Study Director: Maria Jose Faus, PhD, Universidad de Granada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Anticipated)

September 1, 2011

Study Completion (Anticipated)

September 1, 2011

Study Registration Dates

First Submitted

October 29, 2010

First Submitted That Met QC Criteria

November 2, 2010

First Posted (Estimate)

November 3, 2010

Study Record Updates

Last Update Posted (Estimate)

May 6, 2016

Last Update Submitted That Met QC Criteria

May 5, 2016

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMM01-FAR-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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