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

NCT01085474 | Completed

• 1 other identifier: NIS-RES-DUM-2009/1
• Study Type: observational
• Target: 384
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Asthma

Keywords

Asthma; Pharmaceutical intervention; Effect of a pharmaceutical intervention on the level of control of the asthmatic patient

Outcome Measures

Primary Outcomes (1)

• 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.

  First a Pilot in 3 months and then the final study in 6 months

Secondary Outcomes (2)

• Compare disease control in patients who know their medication and those who doesn't.

  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.

  First a Pilot in 3 months and then the final study in 6 months

Study Arms (2)

1

1\. Pilot Study: 60 patients (all in the intervention group) 30 patients with intervention A and 30 patients with B intervention)

Other: 1

2

Main Study: 600 patients (30 pharmacies control group and 30 pharmacies intervention group, 10 patients per pharmacy)

Other: 2

Interventions

1 OTHER

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.

1

2 OTHER

The best intervention used in the pilot study will be chosen and included in the main study.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

60 community pharmacies 10 patients per pharmacy

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Research Site

Madrid, Spain

Location

Malaga

Málaga, Spain

Location

Related Publications (1)

• Garcia-Cardenas V, Sabater-Hernandez D, Kenny P, Martinez-Martinez F, Faus MJ, Benrimoj SI. Effect of a pharmacist intervention on asthma control. A cluster randomised trial. Respir Med. 2013 Sep;107(9):1346-55. doi: 10.1016/j.rmed.2013.05.014. Epub 2013 Jun 28.

  PMID: 23810267 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 12, 2010
• Study Start: April 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 28, 2013

Record last verified: 2013-01

Locations

ES (2)