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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01085474
First received: March 11, 2010
Last updated: January 25, 2013
Last verified: January 2013

March 11, 2010
January 25, 2013
April 2010
July 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Evaluate the effect of a pharmaceutical intervention with self-measurement of MEF on the patients' knowledge of their asthma medication, treatment adherence and level of disease control in asthmatic patients, compared to those who receive usual care. [ Time Frame: First a Pilot in 3 months and then the final study in 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01085474 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To compare maximum expiratory flow between patients with and without knowledge of their treatment [ Time Frame: First a Pilot in 3 months and then the final study in 12 months ] [ Designated as safety issue: No ]
  • To compare maximum expiratory flow between patients who comply to treatment and those who do not comply [ Time Frame: First a Pilot in 3 months and then the final study in 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effect of a Pharmaceutical Intervention on the Level of Control of the Asthmatic Patient
Effect of a Pharmaceutical Intervention on the Level of Control of the Asthmatic Patient

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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

60 community pharmacies 10 patients per pharmacy

Asthma
  • 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.
  • Other: 2
    The best intervention used in the pilot study will be chosen and included in the main study.
  • 1
    1. Pilot Study: 60 patients (all in the intervention group) 30 patients with intervention A and 30 patients with B intervention)
    Intervention: Other: 1
  • 2
    Main Study: 600 patients (30 pharmacies control group and 30 pharmacies intervention group, 10 patients per pharmacy)
    Intervention: Other: 2
García-Cárdenas V, Sabater-Hernández D, Kenny P, Martínez-Martínez 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
384
July 2011
July 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01085474
NIS-RES-DUM-2009/1
No
AstraZeneca
AstraZeneca
Not Provided
Not Provided
AstraZeneca
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP