Evaluating the Effectiveness of Education Session by Pharmacists in Patients with Asthma

• Register: TCTR
• Last refreshed on: 29 April 2024
• Main ID: TCTR20171219001
• Date of registration: 19/12/2017
• Prospective Registration: No
• Primary sponsor: Ministry of Technology and Higher Education of Indonesia
• Public title: Evaluating the Effectiveness of Education Session by Pharmacists in Patients with Asthma
• Scientific title: A Randomized Controlled Trial Evaluating the Effectiveness of Education Session by Pharmacists in Patients with Asthma in Indonesia
• Date of first enrolment: 28/08/2017
• Target sample size: 100
• Recruitment status: Completed
• URL: https://www.thaiclinicaltrials.org/show/TCTR20171219001
• Study type: Interventional
• Study design: Randomized
• Phase: N/A

Countries of recruitment

Indonesia

Contacts

• Name: Elida Zairina
• Affiliation: Universitas Airlangga

• Name: Elida Zairina
• Affiliation: Universitas Airlangga

Key inclusion & exclusion criteria

Inclusion criteria: Eligibility for this trial included patients with asthma who had used any regular medications for asthma within the previous 12 months, aged 18 years or older and able to communicate in Indonesian.
Exclusion criteria: Those who are not able or contra indicated to perform lung function with spirometer will be excluded.

Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Patients with asthma diagnosed
asthma, asthma control, asthma quality of life

asthma, asthma control, asthma quality of life

Intervention(s)

The trial evaluates an intervention involving pharmacists to deliver one-on-one education session about: (1) asthma medication that has been used (2) how to use asthma medication devices correctly (3) asthma symptoms and how to prevent the asthma exacerbations and (4) how to handle asthma triggers and environmental control measures. The intervention group will also be provided with asthma booklet contains about how to use asthma medication correctly and avoiding asthma triggers
A written asthma action plan consistent with Global Initiative for Asthma (GINA) guideline has been translated into Indonesian language and designed for each participant based on information obtained at baseline. The asthma action plan contains instructions on which medications to take when feeling well, how to recognize worsening asthma, what to do when symptoms are getting worse and what to do in the event of an acute attack, including a first aid plan,Participants allocated to the control group received the usual medical care provided by the Department of Pulmonology and/or their healthcare professionals. This included their regular monthly visits depending on their severity or complications. If during follow up, it was apparent that their asthma control had deteriorated since prior assessment (for example; using their reliever two or more times a week, needing to increase their preventer dose), the participant and her health professionals will be notified with participant’s permission.

Experimental Other,No Intervention Other

Education session by pharmacist,Usual Care

Primary Outcome(s)

Changes in asthma control baseline and every 1, 2 and 3 months Asthma Control Questionnaire (ACQ)

Secondary Outcome(s)

Changes in Asthma Quality of Life baseline and every 1, 2 and 3 months Asthma Quality of Life Questionnaire (AQLQ) ,Forced Expiratory Volume in 1 second (FEV1) baseline and every 1, 2 and 3 months Spirometer,asthma-related health visits, days off work/study, and oral corticosteroid use baseline and at 3 months Questionnaire and patient medical records,Adherence score baseline and every 1, 2 and 3 months Adherence to Refills and Medications Scales (ARMS) questionnaire

Secondary ID(s)

Nil Known

Source(s) of Monetary Support

Ministry of Technology and Higher Education of Indonesia

Secondary Sponsor(s)

Ministry of Technology and Higher Education of Indonesia

Ethics review

Status: Submission not required
Approval date:
Contact:

Results

• Date Completed: 31/08/2018