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

Not Applicable

Completed

• Conditions: Asthma COPD
• Interventions: Behavioral: Patient education and counselling

• Registration Number: NCT06417931
• Lead Sponsor: University of Ibadan

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-10-04
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28
• Status Verified: 2024-05
• Study First Submitted: 2024-05-13
• Study First Submitted QC: 2024-05-13
• Last Update Submitted: 2024-05-13
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Patient education and counselling	Patients in the intervention group received education and counselling tips about their disease condition and medications

Primary Outcome Measures

Name	Time	Method
Medication adherence	Two months	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.
Use of inhaler devices	Two months	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.

Secondary Outcome Measures

Name	Time	Method
disease control	Two months	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

Trial Locations

Locations (1)

University College Hospital; 🇳🇬 Ibadan, Oyo State, Nigeria