- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06417931
Medication Adherence and Use of Inhaler Devices in Patients With Asthma or COPD
May 13, 2024 updated by: Uyiose Fortress Ufuah, University of Ibadan
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
130
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oyo State
-
Ibadan, Oyo State, Nigeria, 200212
- University College Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
|
Experimental: Intervention
Patients in the intervention group received education and counselling tips about their disease condition and medications
|
The pharmacist intervention was aimed at identifying and addressing barriers to treatment adherence through tailored strategies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medication adherence
Time Frame: 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.
|
Two months
|
Use of inhaler devices
Time Frame: 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.
|
Two months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
disease control
Time Frame: 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
|
Two months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 4, 2023
Primary Completion (Actual)
February 28, 2024
Study Completion (Actual)
February 28, 2024
Study Registration Dates
First Submitted
May 13, 2024
First Submitted That Met QC Criteria
May 13, 2024
First Posted (Actual)
May 16, 2024
Study Record Updates
Last Update Posted (Actual)
May 16, 2024
Last Update Submitted That Met QC Criteria
May 13, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Medication adherence
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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