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

NCT02046759 | Completed DMC

• 1 other identifier: Asthma-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchial Asthma

Outcome Measures

Primary Outcomes (1)

• Asthma Control Questionnaire

  at baseline & after 2 months of therapy

Secondary Outcomes (5)

• 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 Outcomes (2)

• Assessment of Inhalation Technique

  at baseline and after 2 months of therapy

• Patient Adherence to Therapy

  2 months of therapy

Study Arms (2)

Pharmacist-Intervention

EXPERIMENTAL

Other: Pharmacist- Intervention

Routine Care

ACTIVE COMPARATOR

Other: Routine Care

Interventions

Pharmacist- Intervention OTHER

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.

Also known as: Patient Education, Asthma Action Plan, Shared Decision Making

Pharmacist-Intervention

Routine Care OTHER

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.

Routine Care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient with clinical diagnosis of bronchial asthma
• responsible for administering their own asthma medications.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Asthma

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Rana R Farrag

  Ahram Canadian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist

Study Record Dates

• First Submitted: January 24, 2014
• First Posted: January 28, 2014
• Study Start: March 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 28, 2014

Record last verified: 2014-01

Locations

EG (1)