Effect of a Pharmaceutical Intervention on the Level of Control of the Asthmatic Patient

January 25, 2013 updated by: AstraZeneca
Measurement of disease control, treatment adherence and patient knowledge of his/her medication in patients that are receiving a pharmaceutical intervention compared with those patients who receive regular pharmaceutical care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

384

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
      • Madrid, Spain
        • Research Site
      • Malaga, Spain
        • Malaga

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

Sampling Method

Probability Sample

Study Population

60 community pharmacies 10 patients per pharmacy

Description

Inclusion Criteria:

  • Patients who have given their informed consent and expressed interest in participating in the study
  • Asthmatic Patients

Exclusion Criteria:

  • Patients with communication difficulties.
  • Persons who obtain symbicort but not for their own use.
  • Patients with other major diseases: Heart problems, COPD, EMPHYSEMA, lung cancer, AIDS.
  • Patients with a respiratory infection.
  • Patients with seasonal asthma.
  • Pregnant women
  • Patients who have previously participated in a health education study in asthma.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
1. Pilot Study: 60 patients (all in the intervention group) 30 patients with intervention A and 30 patients with B intervention)
Other: 1
In the pilot study the objective is to compare 2 different pharmaceutical interventions (A and B) and to assess which one improves disease control, patient adherence and patient knowledge of the medication.
2
Main Study: 600 patients (30 pharmacies control group and 30 pharmacies intervention group, 10 patients per pharmacy)
Other: 2
The best intervention used in the pilot study will be chosen and included in the main study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate the effect of the pharmaceutical intervention on the disease control, treatment adherence and patient knowledge of his/her medication using the MEF, treatment adherence and patient knowledge of the medication indicators.
Time Frame: First a Pilot in 3 months and then the final study in 6 months
First a Pilot in 3 months and then the final study in 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare disease control in patients who know their medication and those who doesn't.
Time Frame: First a Pilot in 3 months and then the final study in 6 months
First a Pilot in 3 months and then the final study in 6 months
Compare disease control in patients who comply with their medication with those who doesn't.
Time Frame: First a Pilot in 3 months and then the final study in 6 months
First a Pilot in 3 months and then the final study in 6 months

Collaborators and Investigators

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

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

March 11, 2010

First Submitted That Met QC Criteria

March 11, 2010

First Posted (Estimate)

March 12, 2010

Study Record Updates

Last Update Posted (Estimate)

January 28, 2013

Last Update Submitted That Met QC Criteria

January 25, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-RES-DUM-2009/1

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.

Clinical Trials on Asthma

Clinical Trials on 1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe