A Comparative Study of an Integrated Pharmaceutical Care Plan and a Routine Care in Bronchial Asthma
Primary Purpose
Bronchial Asthma
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pharmacist- Intervention
Routine Care
Sponsored by

About this trial
This is an interventional health services research trial for Bronchial Asthma
Eligibility Criteria
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.
Sites / Locations
- Ain Shams University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pharmacist-Intervention
Routine Care
Arm Description
Outcomes
Primary Outcome Measures
Asthma Control Questionnaire
Secondary Outcome Measures
Forced Expiratory Volume in 1 second (FEV1%)
Rescue Medication SABA (number of puffs used most days)
Inhaled Corticosteroid Use (number of puffs used/day)
Number of courses of systemic steroid used
Number of ER visits/ Hospitalization
Full Information
NCT ID
NCT02046759
First Posted
January 24, 2014
Last Updated
January 24, 2014
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT02046759
Brief Title
A Comparative Study of an Integrated Pharmaceutical Care Plan and a Routine Care in Bronchial Asthma
Official Title
A Comparative Study of an Integrated Pharmaceutical Care Plan and a Routine Care in Bronchial Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the study is to compare the effect of asthma care by clinical pharmacist intervention versus routine care on asthma control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchial Asthma
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pharmacist-Intervention
Arm Type
Experimental
Arm Title
Routine Care
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Pharmacist- Intervention
Other Intervention Name(s)
Patient Education, Asthma Action Plan, Shared Decision Making
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Routine Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Asthma Control Questionnaire
Time Frame
at baseline & after 2 months of therapy
Secondary Outcome Measure Information:
Title
Forced Expiratory Volume in 1 second (FEV1%)
Time Frame
at baseline & after 2 months of therapy
Title
Rescue Medication SABA (number of puffs used most days)
Time Frame
at baseline & after 2 months of therapy
Title
Inhaled Corticosteroid Use (number of puffs used/day)
Time Frame
at baseline & after 2 months of therapy
Title
Number of courses of systemic steroid used
Time Frame
During 2 months of therapy
Title
Number of ER visits/ Hospitalization
Time Frame
During 2 months of therapy
Other Pre-specified Outcome Measures:
Title
Assessment of Inhalation Technique
Time Frame
at baseline and after 2 months of therapy
Title
Patient Adherence to Therapy
Time Frame
2 months of therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rana R Farrag
Organizational Affiliation
Ahram Canadian University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University Hospitals
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
A Comparative Study of an Integrated Pharmaceutical Care Plan and a Routine Care in Bronchial Asthma
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