NCT01233193

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 3, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

May 6, 2016

Status Verified

February 1, 2010

Enrollment Period

1.6 years

First QC Date

October 29, 2010

Last Update Submit

May 5, 2016

Conditions

Hypertension

Keywords

Home blood pressure measurementPharmaceutical ServicesMedication adherencehypertension managementBlood Pressure

Outcome Measures

Primary Outcomes (1)

  • blood pressure control

    Percentage of patients with controlled hypertension

    At 6 months

Secondary Outcomes (1)

  • Adherence

    At 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

The control group receive usual care in the community pharmacy

Interventions

Health education, Home blood pressure monitoringBEHAVIORAL

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.

Also known as: pharmaceutical health education
Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Community Pharmacies

Granada, Andalusia, 18000, Spain

Location

Community Pharmacies

Jaén, Andalusia, 23000, Spain

Location

MeSH Terms

Conditions

HypertensionMedication Adherence

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Maria Jose Faus, PhD

    Universidad de Granada

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 29, 2010

First Posted

November 3, 2010

Study Start

February 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

May 6, 2016

Record last verified: 2010-02

Locations

ES(2)