Efficacy of an Education Session by Pharmacists for Patients With Asthma: Protocol and Design of a Randomized Controlled Trial

BACKGROUND: Asthma is a chronic disease that requires indefinite long-term therapy. Many approaches have been developed to enable people with asthma to live as normally as possible. In medication therapy management, pharmacists could play important roles in supporting the everyday life of asthmatic patients, such as by providing education therapy management to ensure that patients achieve optimal therapeutic outcomes. A good collaboration between health care practitioners and patients will produce a better system in terms of therapeutic management, which will lead to health care cost savings related to emergency visits. Although the Government has made various efforts to manage asthma in Indonesia, without commitment and support from both patients and health care professionals, the expected outcomes cannot be achieved. OBJECTIVE: This study aims to evaluate the effectiveness of an educational intervention provided by pharmacists compared with that of usual care. METHODS: A randomized controlled trial comparing usual care with an education session by pharmacists is underway. The intervention comprises a one-on-one education session of 60 minutes with a pharmacist comprising information regarding (1) asthma medication that has been used; (2) how to use asthma medication devices correctly; (3) asthma symptoms and how to prevent exacerbation of asthma; and (4) how to manage asthma triggers and environmental control measures. The primary outcome measure is change in asthma control, as measured using the Asthma Control Questionnaire. Secondary outcomes include changes in Asthma Quality of Life Questionnaire score, lung function, asthma-related health visits, days off from work or study, and oral corticosteroid use. Research assistants who are masked to the group allocation will collect outcome data at the baseline and every month for a 3-month period. Informed consent will be sought at enrollment and intention-to-treat analysis will be performed. RESULTS: This study was funded in January 2017 and ethical approval was obtained in June 2017. The enrollment was started in August 2017, and about 72 participants have been enrolled. First results are expected to be submitted for publication in 2019. CONCLUSIONS: This is the first study to evaluate the effectiveness of a pharmacist-guided asthma education session compared with that of usual care in Indonesia. If it is proven effective, this intervention program could improve asthma self-management by patients, which may reduce risks of poorly controlled asthma. This intervention could also be implemented in addition to the current usual care for patients with asthma. TRIAL REGISTRATION: Thai Clinical Trials Registry TCTR20171219001; http://www.clinicaltrials.in.th/index.php? tp =regtrials&menu=trialsearch&smenu=fulltext&task=search&task2=view1&id=3068 (Archived by WebCite at http://www.webcitation.org/73Ci5eKtv) INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/10210