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Completed

NCT Number: NCT02046759

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Hospitals

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Patient Education, Asthma Action Plan, Shared Decision Making

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.

Primary outcomes

  1. Asthma Control Questionnaire

    Time frame: at baseline & after 2 months of therapy

Secondary outcomes

  1. Forced Expiratory Volume in 1 second (FEV1%)

    Time frame: at baseline & after 2 months of therapy

  2. Rescue Medication SABA (number of puffs used most days)

    Time frame: at baseline & after 2 months of therapy

  3. Inhaled Corticosteroid Use (number of puffs used/day)

    Time frame: at baseline & after 2 months of therapy

  4. Number of courses of systemic steroid used

    Time frame: During 2 months of therapy

  5. Number of ER visits/ Hospitalization

    Time frame: During 2 months of therapy

Other outcomes

  1. Assessment of Inhalation Technique

    Time frame: at baseline and after 2 months of therapy

  2. Patient Adherence to Therapy

    Time frame: 2 months of therapy

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 28, 2014
Registry last updated
Jan 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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