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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01233193
Other study ID # DMM01-FAR-10
Secondary ID
Status Active, not recruiting
Phase N/A
First received October 29, 2010
Last updated May 5, 2016
Start date February 2010
Est. completion date September 2011

Study information

Verified date February 2010
Source Universidad de Granada
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 140
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Spain Community Pharmacies Granada Andalucia
Spain Community Pharmacies Jaén Andalucia

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary blood pressure control Percentage of patients with controlled hypertension At 6 months No
Secondary Adherence Percentage of adherent patients after 6 months within the trial At 6 months No
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