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

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

Study Overview

• Status: Completed
• Conditions: Bronchial Asthma
• Intervention / Treatment: Other: Pharmacist- Intervention; Other: Routine Care

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Routine Care	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.
Experimental: Pharmacist-Intervention	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 Names: Patient Education; Asthma Action Plan; Shared Decision Making

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Asthma Control Questionnaire	at baseline & after 2 months of therapy

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Assessment of Inhalation Technique	at baseline and after 2 months of therapy
Patient Adherence to Therapy	2 months of therapy

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Rana R Farrag, Ahram Canadian University

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: January 24, 2014
• First Submitted That Met QC Criteria: January 24, 2014
• First Posted (Estimate): January 28, 2014

Study Record Updates

• Last Update Posted (Estimate): January 28, 2014
• Last Update Submitted That Met QC Criteria: January 24, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: Asthma-001