Medication Adherence and Use of Inhaler Devices in Patients With Asthma or COPD

Asthma COPD Clinical Trial

Official title:

A Pharmacist-Led Intervention on Medication Adherence and Inhaler Usage on Clinical Outcomes Among Patients With Asthma and Chronic Obstructive Pulmonary Disease in Ibadan, Nigeria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06417931
• Other study ID #: Medication adherence
• Status: Completed
• Phase: N/A
• Start date: October 4, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: May 2024
• Source: University of Ibadan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the impact of a pharmacist-led intervention programme on medication adherence and use of inhaler devices on clinical outcomes of patients with asthma and COPD attending a tertiary health facility in Nigeria.

Description:

Medication non-adherence in asthma and COPD patients have been established to be very high, and along-side poor knowledge of proper use of inhaler devices, results in suboptimal disease control among these patients. Studies evaluating the impact of a comprehensive intervention on medication adherence and inhaler usage on disease control are scare in developing countries. This study was a prospective single-blind quasi-randomized-controlled study among asthma and COPD patients attending the chest out-patient clinic of the University College Hospital, Ibadan. The baseline questionnaire was administered to consenting patients to explore demographic and specific clinical characteristics, knowledge of the disease, current medications, medication adherence, knowledge of use of metered dose (MDIs) and diskus inhalers, and asthma/COPD control status using the asthma control test (ACT) and COPD assessment test (CAT) scales. Subsequently, patients were assigned into intervention or control groups using odd or even number assignation. Patients in the intervention group were followed up for two months via face to face interviews, short message services, and phone calls at one-weekly intervals, so as to provide education and counseling to resolve the identified gaps during the baseline interaction. Descriptive statistics were used to summarize the data, while chi-square, t-test, Fishers exact test and Wilcoxon-signed ranked tests were used as appropriate to test for associations at p < 0.05.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients 18 years of age and older with a primary diagnosis of asthma or COPD by a physician who are willing to complete the study and have telephone access

Exclusion Criteria:

All non-consenting patients and patients who are not on any medications at any point in the study

Related Conditions & MeSH terms

• Asthma
• Asthma COPD

Intervention

Behavioral:
• Patient education and counselling
The pharmacist intervention was aimed at identifying and addressing barriers to treatment adherence through tailored strategies

Locations

Country	Name	City	State
Nigeria	University College Hospital	Ibadan	Oyo State

Sponsors (1)

Lead Sponsor	Collaborator
University of Ibadan

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication adherence	The difference between the intervention and control groups with respect to the changes in the medication adherence score from baseline to a 2-month follow-up.	Two months
Primary	Use of inhaler devices	The difference between the intervention and control groups with respect to the changes in knowledge of the use of inhaler devices from baseline to a 2-month follow-up.	Two months
Secondary	disease control	The difference in asthma or Chronic obstructive pulmonary disease (COPD) control among patients in control and intervention groups from baseline to 2-months follow-up	Two months