A Comparative Study of an Integrated Pharmaceutical Care Plan and a Routine Care in Bronchial Asthma

Overview

The aim of the study is to compare the effect of asthma care by clinical pharmacist intervention versus routine care on asthma control.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2013

Interventions

  • Other: Pharmacist- Intervention
    • Patients received additional education on basic facts about asthma, role of medications, the difference between long-term control medications and quick-relief medications, as well as patient skills in the first visit then reinforcement every two weeks.. The importance of proper inhaler technique, avoidance of asthma triggers and self-monitoring of asthma were also highlighted. Visual aids, physical demonstration as well as written information resources were supplied. Asthma care plans were tailored to patient needs and preferences. Patients were informed how to detect early signs of worsening asthma, when and how to seek medical care as appropriate.
  • Other: Routine Care
    • Patients received usual care delivered by physician without pharmacist intervention. Patients were prescribed asthma medication with summarized basic information on asthma and medication use. Follow-up visits were not planned on consistent basis, but rather individually according to the disease status. No asthma action plans were provided.

Arms, Groups and Cohorts

  • Experimental: Pharmacist-Intervention
  • Active Comparator: Routine Care

Clinical Trial Outcome Measures

Primary Measures

  • Asthma Control Questionnaire
    • Time Frame: at baseline & after 2 months of therapy

Secondary Measures

  • Forced Expiratory Volume in 1 second (FEV1%)
    • Time Frame: at baseline & after 2 months of therapy
  • Rescue Medication SABA (number of puffs used most days)
    • Time Frame: at baseline & after 2 months of therapy
  • Inhaled Corticosteroid Use (number of puffs used/day)
    • Time Frame: at baseline & after 2 months of therapy
  • Number of courses of systemic steroid used
    • Time Frame: During 2 months of therapy
  • Number of ER visits/ Hospitalization
    • Time Frame: During 2 months of therapy

Participating in This Clinical Trial

Inclusion Criteria

  • patient with clinical diagnosis of bronchial asthma – responsible for administering their own asthma medications. Exclusion Criteria:

  • patients who were not responsible for administering their own asthma medications. – patients with cognitive defects, other pulmonary disease e.g. Chronic Obstructive Pulmonary Disease (COPD), experiencing illness with asthma-like symptoms e.g. Congestive Heart Failure, evidence of fixed airway obstruction – patients unavailable for 2-month follow-up. – patients who did not provide written informed consent.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ain Shams University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rana Rasheed Ibrahim Farrag, Pharmacist – Ain Shams University
  • Overall Official(s)
    • Rana R Farrag, Principal Investigator, Ahram Canadian University

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