Back to resultsThe Effect of Pharmacist Intervention on Blood Pressure Control (AFenPA)
Primary Purpose
Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Health education, Home blood pressure monitoring
Sponsored by
About this trial
This is an interventional supportive care trial for Hypertension focused on measuring Home blood pressure measurement, Pharmaceutical Services, Medication adherence, hypertension management, Blood Pressure
Eligibility 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)
Sites / Locations
- Community Pharmacies
- Community Pharmacies
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
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
The control group receive usual care in the community pharmacy
Outcomes
Primary Outcome Measures
blood pressure control
Percentage of patients with controlled hypertension
Secondary Outcome Measures
Adherence
Percentage of adherent patients after 6 months within the trial
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01233193
Brief Title
The Effect of Pharmacist Intervention on Blood Pressure Control
Acronym
AFenPA
Official Title
Pharmacist Intervention Effect on the Medication Adherence and Blood Pressure Control in Treated Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Universidad de Granada
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Home blood pressure measurement, Pharmaceutical Services, Medication adherence, hypertension management, Blood Pressure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group receive usual care in the community pharmacy
Intervention Type
Behavioral
Intervention Name(s)
Health education, Home blood pressure monitoring
Other Intervention Name(s)
pharmaceutical health education
Intervention Description
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.
Primary Outcome Measure Information:
Title
blood pressure control
Description
Percentage of patients with controlled hypertension
Time Frame
At 6 months
Secondary Outcome Measure Information:
Title
Adherence
Description
Percentage of adherent patients after 6 months within the trial
Time Frame
At 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Jose Faus, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Study Director
Facility Information:
Facility Name
Community Pharmacies
City
Granada
State/Province
Andalucia
ZIP/Postal Code
18000
Country
Spain
Facility Name
Community Pharmacies
City
Jaén
State/Province
Andalucia
ZIP/Postal Code
23000
Country
Spain
12. IPD Sharing Statement
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The Effect of Pharmacist Intervention on Blood Pressure Control
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