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

Bronchial Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02046759
• Other study ID #: Asthma-001
• Status: Completed
• Phase: N/A
• First received: January 24, 2014
• Last updated: January 24, 2014
• Start date: March 2012
• Est. completion date: January 2013

Study information

• Verified date: January 2014
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

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.
• 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.

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of Inhalation Technique		at baseline and after 2 months of therapy	No
Other	Patient Adherence to Therapy		2 months of therapy	No
Primary	Asthma Control Questionnaire		at baseline & after 2 months of therapy	No
Secondary	Forced Expiratory Volume in 1 second (FEV1%)		at baseline & after 2 months of therapy	No
Secondary	Rescue Medication SABA (number of puffs used most days)		at baseline & after 2 months of therapy	No
Secondary	Inhaled Corticosteroid Use (number of puffs used/day)		at baseline & after 2 months of therapy	No
Secondary	Number of courses of systemic steroid used		During 2 months of therapy	No
Secondary	Number of ER visits/ Hospitalization		During 2 months of therapy	No