Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Universidad de Granada.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Universidad de Granada
ClinicalTrials.gov Identifier:
NCT01233193
First received: October 29, 2010
Last updated: March 18, 2011
Last verified: February 2010
  Purpose

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 Intervention
Hypertension
Behavioral: Health education, Home blood pressure monitoring

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Pharmacist Intervention Effect on the Medication Adherence and Blood Pressure Control in Treated Patients

Resource links provided by NLM:


Further study details as provided by Universidad de Granada:

Primary Outcome Measures:
  • blood pressure control [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    Percentage of patients with controlled hypertension


Secondary Outcome Measures:
  • Adherence [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    Percentage of adherent patients after 6 months within the trial


Estimated Enrollment: 140
Study Start Date: February 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: October 29, 2010
Last Updated: March 18, 2011
Health Authority: Spain: Ethics Committee

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

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014